FDA Adverse Event
Death
Summary report: N
X SERIES
MDR report key: 3231266
·
Received July 5, 2013
Report
- Report Number
- 1220908-2013-01841
- Event Type
- Death
- Date Received
- July 5, 2013
- Date of Event
- June 23, 2013
- Report Date
- June 24, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 ATTEMPTING TO MONITOR A TWO YEAR OLD MALE PT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE MONITORING THE PT. HOWEVER, THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308560 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Death |