FDA Adverse Event
Malfunction
Summary report: N
1220648-1999-00039
MDR report key: 257190
·
Received December 28, 1999
Report
- Report Number
- 1220648-1999-00039
- Event Type
- Malfunction
- Date Received
- December 28, 1999
- Date of Event
- December 15, 1999
- Report Date
- December 28, 1999
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
DURING A ROUTINE "PM" THE BIOMEDICAL ENGINEER NOTICED SOME CORROSION ON THE RIGHT SIDE BATTERY TERMINAL. THE BATTERIES WERE REPLACED AND THE SYSTEM IS FUNCTIONING PER SPECIFICATIONS. THE SUSPECT BATTERIES HAVE BEEN RETURNED TO ABIOMED FOR EVALUATION.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |