FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART FRX
MDR report key: 4840025
·
Received June 12, 2015
Report
- Report Number
- 3030677-2015-01439
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Report Date
- May 22, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 050004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK. THERE WAS NO NEGATIVE PATIENT IMPACT.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK. THERE WAS NO NEGATIVE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386597 | HEARTSTART FRX | AED | MKJ | PHILIPS MEDICAL SYSTEMS | 861304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |