FDA Adverse Event
Malfunction
Summary report: N
AED PRO
MDR report key: 2212954
·
Received July 12, 2011
Report
- Report Number
- 1220908-2011-01888
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Report Date
- June 22, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, A CLINICAL USER PRESSED THE SHOCK BUTTON WITHOUT ADVISING OTHER CLINICIANS TO STAND CLEAR AND ANOTHER CLINICAL USER RECEIVED AN UNINTENDED DELIVERY OF ENERGY WHILE PERFORMING CPR ON THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT OR THE USER 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 | UNK |