FDA Adverse Event
Summary report: N
FR2
MDR report key: 1942511
·
Received November 23, 2010
Report
- Report Number
- 3030677-2010-00355
- Date Received
- November 23, 2010
- Report Date
- November 23, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 03065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVESTIGATION PENDING.
Description of Event or Problem · 1
COMMUNICATION FROM DISTRIBUTOR INDICATES THAT AED PROMPTED LOW BATTERY DURING DEPLOYMENT. COMMUNICATION INDICATES THAT BATTERY REPLACEMENT (4X) DID NOT CORRECT DEVICE BEHAVIOR. DATE OF EVENT NOT KNOWN AT THIS TIME. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FR2 | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M3840A-ABS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |