FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3982635
·
Received June 16, 2014
Report
- Report Number
- 1218950-2014-03439
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Report Date
- May 27, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX WAS "NO LONGER ABLE TO READ THE ELECTROCARDIOGRAM (ECG)" AS IT HAD A "FLAT LINE". THERE WAS NO ERROR MESSAGES AND THE DEVICE WORKED WITH THE PADDLES BUT NOT THE ELECTRODES. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353531 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |