FDA Adverse Event
Death
Summary report: N
RESPONDER 1250
MDR report key: 104801
·
Received July 10, 1997
Report
- Report Number
- 2124823-1997-00048
- Event Type
- Death
- Date Received
- July 10, 1997
- Date of Event
- June 8, 1997
- Report Date
- June 9, 1997
- Manufacturer
- MARQUETTE ELECTRONICS, INC.
- Product Code
- MKJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SECTION H.3 EVALUATION SUMMARY ATTACHMENT: MANUFACTURER PERFORMED EXTENSIVE TESTING ON THE DEVICE. THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED. DEVICE HAS MET ALL MFG SPECIFICATIONS. CAUSAL RELATIONSHIP OF DEVICE TO THIS INCIDENT IS UNDETERMINED. WILL MONITOR FOR FREQUENCY AND SEVERITY. SEE DISCLAIMER.
Description of Event or Problem · 1
CUSTOMER RESPONDED TO 79 Y/O MALE IN V-TACH ON ARRIVAL. PT WAS CONNECTED TO DEVICE AND IV'S WERE STARTED. APPROX TWO MINUTES INTO THE CALL, CUSTOMER ALLEGES DEVICE DISPLAYED FAULT MESSAGE. CUSTOMER OVER RODE TO MANUAL OPERATION AND DELIVERED ONE SHOCK, PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESPONDER 1250 | DEFIBRILLATOR, D.C. | MKJ | MARQUETTE ELECTRONICS, INC. | 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |