FDA Adverse Event
Malfunction
Summary report: N
FR3, REFURB TEXT AED - US ENGLISH
MDR report key: 3823316
·
Received February 19, 2014
Report
- Report Number
- 3030677-2014-00601
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Report Date
- February 5, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K111693
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED IS NOT FUNCTIONING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105201 | FR3, REFURB TEXT AED - US ENGLISH | MKJ | MKJ | PHILIPS MEDICAL SYSTEMS | 861388 | M54169-1327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |