FDA Adverse Event
Malfunction
Summary report: N
FAST-PATCH PLUS DISPOSABLE DEFIBRILLATION/ECG ELECTRODES WIT
MDR report key: 298850
·
Received September 26, 2000
Report
- Report Number
- 3015876-2000-00444
- Event Type
- Malfunction
- Date Received
- September 26, 2000
- Report Date
- September 20, 2000
- Manufacturer
- MEDTRONIC PHYSIO-CONTROL CORP.
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A MEDWATCH REPORT WAS REC'D WITH THE FOLLOWING EVENT DESCRIPTION: THE MEDTRONIC PHYSIO-CONTROL EDGE SYSTEM FAST PATCH PLUS PACKAGES (3010188-007 AND 3010188-06) ARE VERY SIMILAR TO THE QUICK-COMBO PACKAGES (3010188-005). THESE TWO DIFFERENT UNITS, HOWEVER ARE TOTALLY INCOMPATIBLE. THESE UNITS ARE USED WITH DEFIBRILLATORS. A MIXUP COULD RESULT IN SIGNIFICANT DELAY IN DEFIBRILLATION, RESULTING IN ADVERSE PT OUTCOME. BETTER IDENTIFICATION NEEDS TO BE DEVISED FOR THE PACKAGING IN WHICH THESE UNITS ARE PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-PATCH PLUS DISPOSABLE DEFIBRILLATION/ECG ELECTRODES WIT | ELECTRODES | MLN | MEDTRONIC PHYSIO-CONTROL CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |