FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART ONSITE
MDR report key: 4853192
·
Received June 18, 2015
Report
- Report Number
- 3030677-2015-01474
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Report Date
- June 11, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Removal / Correction Number
- Z-0642-2013, Z-0643-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
(B)(4). SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK. THERE WAS NO NEGATIVE PATIENT IMPACT.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK. THERE WAS NO NEGATIVE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396527 | HEARTSTART ONSITE | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |