Device product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Z-1415-2022
Product summary
- Event
- Event 90511
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136 mattresses
- Official record key
device-enforcement:Z-1415-2022
Official wording
Reason: The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
Code information: UDI 00887761977945; Serial numbers: W238BP4338, W238BP4339, W238BP4340, W238BP4341, W238BP4342, W238BP4344, W238BP4345, W238BP4347, W238BP4348, W355BP6966, W355BP6978, W355BP6979, W355BP6980, W355BP6981, W355BP6982, W355BP6986, W355BP6987, W355BP6988, W355BP6989, W355BP6990, W357BP6994, W357BP6996, W357BP6997, W357BP6998, W357BP7006, W357BP7007, W357BP7009, W357BP7012, W357BP7015, W357BP7016, W357BP7017, W357BP7018, W357BP7019, W357BP7021, W357BP7022, W357BP7023, W357BP7024, W357BP7025, W357BP7026, W357BP7027, W354BP6891, W354BP6892, W354BP6897, W354BP6898, W354BP6899, X003BP7030, X003BP7031, X003BP7036, X003BP7037, X003BP7039, X003BP7040, X003BP7041, X003BP7047, X003BP7049, X003BP7050, X005BP7090, X005BP7091, X005BP7096, X005BP7097, X005BP7098, W354BP6921, W354BP6922, W354BP6923, W354BP6931, W354BP6932, X005BP7087, X005BP7088, X005BP7089, X005BP7094, X005BP7095, W354BP6910, W354BP6911, W354BP6918, W354BP6936, W354BP6939, W355BP6945, X003BP7055, X003BP7057, X005BP7059, X005BP7060, X005BP7061, X005BP7064, X005BP7065, X005BP7066, X005BP7067, X005BP7083, X005BP7086, X005BP7093, X005BP7104, X005BP7106, X005BP7110, X005BP7111, W354BP6908, W354BP6909, W354BP6916, W354BP6917, W354BP6919, W354BP6920, W354BP6924, W354BP6925, W354BP6926, W354BP6927, W354BP6928, W354BP6929, W354BP6933, W354BP6934, W354BP6935, W354BP6940, W354BP6941, W354BP6942, W355BP6944, W355BP6946, W355BP6948, W355BP6949, W355BP6950, W355BP6951, W355BP6952, W355BP6953, W355BP6955, W355BP6956, W355BP6957, W355BP6958, W355BP6959, W355BP6960, W355BP6961, W355BP6976, W355BP6977, W355BP6983, W355BP6984, W355BP6985, X005BP7084, X005BP7085, X005BP7108, X005BP7109, W354BP6906, and W354BP6930.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
Derived failure modes
-
Unknown
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.