FDA Adverse Event
Malfunction
Summary report: N
AED PLUS
MDR report key: 2911281
·
Received December 11, 2012
Report
- Report Number
- 1220908-2012-03357
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 28, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K011541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A PATIENT, AFTER ONE SUCCESSFULLY DELIVERED SHOCK, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. THE CLINICIAN SUBSEQUENTLY DID NOT ADMINISTER THE SHOCK TO THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PLUS | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |