FDA Adverse Event
Malfunction
Summary report: N
AD PRO
MDR report key: 2081702
·
Received April 12, 2011
Report
- Report Number
- 1220908-2011-01022
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- December 28, 2010
- Report Date
- March 28, 2011
- Manufacturer
- ZOLL MEDICAL CORP.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP. HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT IN CARDIAC ARREST, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AD PRO | DEFIBRILALTOR | MKJ | ZOLL MEDICAL CORP. | AED PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |