Device product
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Z-0360-2016
Product summary
- Event
- Event 72649
- Status
- Terminated
- Classification
- Class I
- Quantity
- 34
- Official record key
device-enforcement:Z-0360-2016
Official wording
Reason: There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
Code information: ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and ASHK-0087.
Distribution pattern: US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
Derived failure modes
-
Unknown
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.