FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2142588
·
Received June 21, 2011
Report
- Report Number
- 1218950-2011-01766
- 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
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED A PACER FAILURE DURING TESTING. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED; HOWEVER, THE EVENT SUMMARY SHOWED ERRORS SUPPORTING THAT A MALFUNCTION OCCURRED. MULTIPLE PARTS WERE REPLACED DUE TO THESE ERRORS. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING ALL TESTING. WE CANNOT DETERMINE THE CAUSE OF THE MALFUNCTION AS MULTIPLE PARTS WERE REPLACED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A PACER FAILURE DURING TESTING.
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 |