FDA Adverse Event
Death
Summary report: N
M SERIES
MDR report key: 1842716
·
Received September 17, 2010
Report
- Report Number
- 1220908-2010-02648
- Event Type
- Death
- Date Received
- September 17, 2010
- Report Date
- August 26, 2010
- Manufacturer
- ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
- Product Code
- MKJ
- PMA / PMN Number
- K990762
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION 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 DEFIBRILLATING A FEMALE, ASYSTOLIC PATIENT, THE PATIENT DID NOT REACT WHEN THE DEVICE'S SHOCK BUTTON WAS PRESSED. THE NURSES INDICATED THAT THE PATIENT WAS 92 DEGREES AND MAY HAVE ALREADY BEEN EXPIRED. COMPLAINANT INDICATED THAT THE CLINICIAN RECEIVED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFER TO MEDWATCH NUMBERS 1220908-2010-02635 AND 1220908-2010-02652 FOR THE SUBSEQUENT DEVICES USED IN THE PATIENT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |