FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2000139
·
Received February 18, 2011
Report
- Report Number
- 1218950-2011-00449
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Report Date
- January 19, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS FIELD SERVICE ENGINEER, AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS HEALTHCARE | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |