FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2142592
·
Received June 21, 2011
Report
- Report Number
- 1218950-2011-01763
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- May 23, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD LOCK UP (STOP OPERATION) DURING THE CHARGE TEST SEGMENT OF THE OPERATIONAL CHECK. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE MALFUNCTION. THE MALFUNCTION WAS RESOLVED BY REPLACEMENT OF THE PROCESSOR PCA AND RELOADING THE SOFTWARE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE WOULD LOCK UP (STOP OPERATION) DURING THE CHARGE TEST SEGMENT OF THE OPERATIONAL CHECK. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |