FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART FR3, ECG, BASIC BUNDLE, JAPAN
MDR report key: 4122131
·
Received September 19, 2014
Report
- Report Number
- 3030677-2014-02091
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Report Date
- September 12, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K111693
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
PR#: (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 DID NOT PASS SELF-DIAGNOSTIC CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583349 | HEARTSTART FR3, ECG, BASIC BUNDLE, JAPAN | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHILIPS MEDICAL SYSTEMS | 861389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |