FDA Adverse Event
Death
Summary report: N
ONE STEP COMPLETE ELECTRODE
MDR report key: 1663799
·
Received April 16, 2010
Report
- Report Number
- 1220908-2010-00923
- Event Type
- Death
- Date Received
- April 16, 2010
- Report Date
- March 31, 2010
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS INDICATED THAT THE ELECTRODE PADS WERE DISCARDED, AND WILL NOT BE RETURNED TO ZOLL FOR EVALUATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PLACE ELECTRODE PADS ONTO A PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER, IT WAS NOT RELATED TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE STEP COMPLETE ELECTRODE | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-0214 | 0810A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |