Device product
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Z-2441-2020
Product summary
- Event
- Event 85685
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 devices
- Official record key
device-enforcement:Z-2441-2020
Official wording
Reason: Failures were found in the temperature measurement function while in the predict mode.
Code information: Serial Numbers: 456802000001~456802000180
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Failures were found in the temperature measurement function while in the predict mode.