FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART SLA BATTERY
MDR report key: 3905067
·
Received June 10, 2014
Report
- Report Number
- 1218950-2014-03251
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- May 21, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DQA
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A LOW BATTERY. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342352 | HEARTSTART SLA BATTERY | DQA, MKJ, LDD, DRO | DQA | PHILIPS MEDICAL SYSTEMS | M3516A | R-2011-09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |