FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM FR2
MDR report key: 3201308
·
Received June 26, 2013
Report
- Report Number
- 3030677-2013-01048
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- June 21, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REPORTED AS ISSUE COULD NOT BE CLEARED BY OPERATOR. DUE TO AGE OF DEVICE, 11 YEARS, DEVICE WILL NOT BE REPLACED. CUSTOMER HAS BEEN ADVISED TO REMOVE FROM SERVICE.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DEVICE VOICE PROMPTS ARE NOT FUNCTIONING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290538 | HEARTSTREAM FR2 | MKJ | PHILIPS MEDICAL SYSTEMS | M3841A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |