FDA Adverse Event
Death
Summary report: N
X-SERIES
MDR report key: 4176775
·
Received September 29, 2014
Report
- Report Number
- 1220908-2014-02545
- Event Type
- Death
- Date Received
- September 29, 2014
- Date of Event
- September 20, 2014
- Report Date
- September 22, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
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 (B)(6) MALE PT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE RADS. COMPLAINANT OBTAINED ANOTHER DEVICE USING THE SAME ELECTRODES TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THE PT SUBSEQUENTLY EXPIRED. PLEASE REF MEDWATCH REPORT NUMBER: 1220908-2014-02553 FOR THE SECOND DEVICE USED DURING THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 605259 | X-SERIES | DEFIBRILALLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death |