FDA Adverse Event
Death
Summary report: N
ZOLL MEDICAL CORPORATION
MDR report key: 929875
·
Received May 2, 2007
Report
- Report Number
- 929875
- Event Type
- Death
- Date Received
- May 2, 2007
- Date of Event
- April 19, 2007
- Report Date
- May 2, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT FOUND PULSELESS AND UNRESPONSIVE IN ROOM. FULL CODE INITIATED. ZOLL MONITOR STAT PADS APPLIED TO PATIENT, LEAD SELECTION CHECKED AND THE SETTING WAS ON PADS. ERROR MESSAGE RECEIVED "DEFIB PAD SHORT." CPR WAS CONTINUED WHILE THE MONITOR WAS CHANGED TO LEAD SETTING FOR MANUAL ATTEMPT TO IDENTIFY HEART RHYTHM. HEART RHYTHM WAS ASYSTOLE. MD NOTIFICATION WAS TAKING PLACE DURING THIS PROCESS AND HE ORDERED FOR CPR TO BE TERMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOLL MEDICAL CORPORATION | DEFIBRILATOR | MKJ | ZOLL MEDICAL CORPORATION | M SERIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death |