Device product
TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
Z-1816-2017
Product summary
- Firm
- Hill-Rom, Inc.
- Event
- Event 76506
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3037
- Official record key
device-enforcement:Z-1816-2017
Official wording
Reason: The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
Code information: P1900 SN: K328AM6065 to Q245AM0691 PR1900 SN: L082AL7316 to R343AL4516 U1900 SN: L257AM0541 to O311AM7169 Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).
Distribution pattern: US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS
Derived failure modes
-
Unknown
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.