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FDA SAFETY ALERT:
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Tabbert, or “TAB” Crib Model C-374 |
Midmark, Inc., (800) 643-6275 |
Hill-Rom, Model 249 | Hill-Rom Company, Inc., (800) 934-7777 |
TODAY Crib, Model C-374 | InterRoyal Corp., (212) 686-3500 |
In both known cases involving fatalities, the accident occurred because the security top was not properly latched. Improper latching could result from either: (1) lowering the security top AFTER raising the side rail, causing the latching tabs to rest outside the top or the side rail (Figure 2), or (2) raising the side rail, by grasping it towards one end rather than in the middle, causing only that the end to lock into place. This would increase the gap between the bottom edge of the security top and the top of the side rail at the unlocked end (see Figure 3). To properly engage the security top, the security top must be lowered FIRST. Then the side rail must be grasped in the middle and raised, assuring that both ends are locked and that the latching tabs on the security top rest BEHIND the top of the side rail (see Figure 4).
Inadequate latching may also result from improper installation of the security top. When the top is installed, the gap between the bottom edges of the security top and the top edges of both side rails must not exceed one inch (1”). Otherwise the latching tabs may not catch hold behind the side rails. Since the cribs and tops have been produced by several manufactures, the possibility exits that they are not all identical. This may cause excessive gaps if cribs and tops are interchanged. Excessive gaps may also result from damaged (bent), corroded, or dirty security top support posts.
Midmark, on December 16, 1983, initiated corrective action by letter notification and by providing a retrofit kit with larger security top latching tabs, warning decals, and undated instructions. Hill-Rom (May 18, 1984), Cambridge (June 7, 1984), and Whittaker (March 6, 1984) have also initiated this action for their customers. The manufacturers are doing their best to locate all cribs, but we are concerned that surplus cribs may have been sold without transfer records, or that the same or similar cribs may have been sold by other distributors under different brand or model designations.
It is extremely important to take measures to prevent further mishaps in pediatric wards. EVEN WITH THE RETROFIT KIT INSTALLED, IMPROPER OPERATION CAN CREATE THE ENTRAPMENT HAZARD. We suggest the following preventive measures:
Schedule preventive maintenance for all cribs and security tops of this design, especially for the latching mechanisms of both the side rails and security tops. Make sure the gap between BOTH side rails and the security top does not exceed one inch. Consider labeling the cribs and corresponding tops to avoid future interchanging. If you have trouble achieving the proper gap, contact the appropriate manufacturer(s).
If it is necessary for parents (or other visitors) to operate the crib or security top, make sure they are properly instructed to ensure safe operation.
If you own or are aware of similar cribs and tops from manufacturers not mentioned in this alert, or if you have any other questions, please contact Mr. Young at the phone number above. Reports of entrapment incidents or other crib problems may be directed to : Dr. Joseph G. Valentino, Product Problem Reporting Program, The United States Pharmacopoeia, 12601 Twinbrook Parkway, Rockville, MD 20852, (800-638-6725).
We appreciate your cooperation, and hope this information will help prevent further mishaps.
Sincerely yours,
John C. Villforth
Director
Center for Devices and Radiological Health
Updated March 9, 2006
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