FDA Adverse Event
Malfunction
Summary report: N
AED PRO
MDR report key: 2072020
·
Received April 20, 2011
Report
- Report Number
- 1220908-2011-01078
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 30, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A (B)(6), MALE PT, THE DEVICE RETURNED A "NO SHOCK ADVISED" DETERMINATION FOR WHAT APPEARED TO BE A SHOCKABLE RHYTHM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |