FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1070643
·
Received July 1, 2008
Report
- Report Number
- 1220908-2008-01392
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- May 7, 2008
- Report Date
- June 10, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
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, THE DEVICE WAS ATTACHED TO THE PATIENT VIA ELECTRODE PADS, CPR WAS INITIATED, AND A RHYTHM WAS ESTABLISHED. THE DEVICE RETURNED A "NO SHOCK ADVISED" DETERMINATION FOR WHAT APPEARED TO BE A SHOCKABLE RHYTHM. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT USING THE SAME ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |