FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3170826
·
Received June 6, 2013
Report
- Report Number
- 1218950-2013-02189
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Report Date
- May 15, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
THE CUSTOMER REPORTED THAT THE DEVICE DISPLAY IS BLANK, HOWEVER, THE DEVICE IS STILL BEEPING, DOING EVERYTHING AND ALSO TALKING IN AED. THE CUSTOMER DID NOT STATE THAT PT HARM OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251924 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |