| Model Number |
A1 |
| Medical Device Problem Code |
Failure to Run on Battery (1466)
|
| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
|
| Date of Event |
09/02/2026
|
|
Type of Reportable Event
|
Malfunction
|
|
Event or Problem Description
|
|
It was reported that there was a battery failure that could cause loss of mechanical ventilation during pre-use checkout.There was no patient involvement.
|
| |
|
Additional Manufacturer Narrative
|
|
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The battery was replaced to resolve the issue.Block a: no report of patient involvement.Legal manufacturer:
hcs madison.(b)(6).
|
| |
|
Search Alerts/Recalls
|