FDA Adverse Event
Death
Summary report: N
1310P MEDITRACE 2/PK 20/CA
MDR report key: 813827
·
Received February 5, 2007
Report
- Report Number
- 9681860-2007-00002
- Event Type
- Death
- Date Received
- February 5, 2007
- Date of Event
- January 26, 2007
- Report Date
- February 1, 2007
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- LDD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO/KENDALL HEALTHCARE IN 2007 THAT THE PADS ARE DISCOLORED AND THE GEL IS NOT STICKY. THE OFFICER ARRIVED AT THE SCENE AND ATTEMPTED TO APPLY THE PADS. THE AED FLASHED "APPLY ELECTRODES". THEY RE-CHECKED THE CONNECTIONS, AND STILL RECEIVED SAME ERROR. THEY THEN REPLACED PADS. EMS ARRIVED PRIOR TO RE-CONNECTING THE AED. PATIENT LATER EXPIRED. AED WAS ALSO CHECKED, AND WORKED AS IT SHOULD. THE LIEUTENANT STATED THAT PADS ARE STORED IN AN OFFICE ENVIRONMENT. THEY ARE KEPT IN THE CRUISERS GLOVE COMPARTMENTS DURING THE OFFICERS' 8 HOUR SHIFTS, AND AT TIMES ARE EXPOSED TO HOT/COLD TEMPERATURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1310P MEDITRACE 2/PK 20/CA | DEFIBRILLATION ELECTRODES | LDD | TYCO HEALTHCARE/KENDALL | 31319281 | 518601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |