FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3170894
·
Received June 5, 2013
Report
- Report Number
- 1218950-2013-02121
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Report Date
- May 9, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- 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). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER STATES THAT THE DEVICE HAD A SHOCK AND PACER MALFUNCTION INOP DURING OP CHECK DUE TO THE DEVICE FROZE UP AT REQUEST TO PRESS CHARGE BUTTON. CUSTOMER STATES NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249384 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |