FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART ONSITE
MDR report key: 4786969
·
Received May 21, 2015
Report
- Report Number
- 3030677-2015-01218
- Event Type
- Malfunction
- Date Received
- May 21, 2015
- Report Date
- April 27, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE OF PR 4113819 WITH MDR 3030677-2015-01119. DEVICE EVALUATION IS PENDING. THIS IS A DUPLICATE OF PR 4113819 WITH MDR 3030677-2015-01119.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE IS NOT FUNCTIONING PROPERLY. THERE WAS NO NEGATIVE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332866 | HEARTSTART ONSITE | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |