FDA Adverse Event
Malfunction
Summary report: N
SOLID GEL MFE, ADULT
MDR report key: 951032
·
Received April 20, 2007
Report
- Report Number
- 1220908-2007-00818
- Event Type
- Malfunction
- Date Received
- April 20, 2007
- Report Date
- April 4, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PACKAGE OF ELECTRODES WERE OPENED AND THE PACKAGE WAS EMPTY. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLID GEL MFE, ADULT | DEFIB/PACING ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-4000 | 0307A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |