FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2142591
·
Received June 21, 2011
Report
- Report Number
- 1218950-2011-01762
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- May 23, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS CUSTOMER REPORTED AN INTERMITTENT PACER FAILURE IN OP-CHECK. THE DEVICE WAS EVALUATED AT PHILIPS AND THE REPORTED SYMPTOM WAS REPRODUCED. THE POWER PCA WAS REPLACED TO RESOLVE THE SYMPTOM.
Description of Event or Problem · 1
THIS CUSTOMER REPORTED AN INTERMITTENT PACER FAILURE IN OP-CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS HEALTHCARE - ANDOVER | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |