FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART ONSITE
MDR report key: 3202244
·
Received June 28, 2013
Report
- Report Number
- 3030677-2013-01078
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Report Date
- June 24, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- 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. DATE OF MANUFACTURE: MAY 2013.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THE AED IS NOT FUNCTIONING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295332 | HEARTSTART ONSITE | MKJ | PHILIPS MEDICAL SYSTEMS | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |