FDA Adverse Event
Death
Summary report: N
3202674-000 REDI-PAK 1P 10B 50
MDR report key: 590290
·
Received April 7, 2005
Report
- Report Number
- 1219103-2005-00003
- Event Type
- Death
- Date Received
- April 7, 2005
- Date of Event
- March 16, 2005
- Report Date
- April 7, 2005
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WHEN THE MEDTRONIC LP500 AED WAS USED WITH THE SET OF THE PM20020 ELECTRODES, THE AED ALARMED "CONNECT ELECTRODES" AND WOULDN'T ANALYZE OR SHOCK THE PT. THE LOT NUMBER IS UNK. THE CUSTOMER PURCHASED THIS PRODUCT FROM MEDTRONIC IN 2/2003. THE END-USER WAS NOT ABLE TO PROVIDE A SAMPLE. NO ADDITIONAL INFO IS AVAILABLE ABOUT THE OUTCOME OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3202674-000 REDI-PAK 1P 10B 50 | DEFIBRILLATION PADS | LDD | TYCO HEALTHCARE/KENDALL | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |