FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART SLA BATTERY
MDR report key: 2862292
·
Received November 5, 2012
Report
- Report Number
- 1218950-2012-03689
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Report Date
- September 18, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DQA
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED A BAD BATTERY AND THE DEVICE DID NOT POWER UP. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER EVALUATED THE BATTERY AND DETERMINED IT WAS FAULTY. THE CUSTOMER WAS PROVIDED INFORMATION PER (B)(6). THIS A MALFUNCTION OF THE BATTERY WHERE THE DEVICE FAILED TO POWER UP.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A BAD BATTERY AND THE DEVICE DID NOT POWER UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART SLA BATTERY | DQA, MKJ, LDD, DRO | DQA | PHILIPS MEDICAL SYSTEMS | M3516A | R-2011-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |