FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART ONSITE
MDR report key: 4751450
·
Received May 1, 2015
Report
- Report Number
- 3030677-2015-01103
- Event Type
- Malfunction
- Date Received
- May 1, 2015
- Report Date
- April 17, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NTO BE CLEARED BY OPERATOR.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED IS NOT FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289621 | HEARTSTART ONSITE | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |