FDA Adverse Event
Death
Summary report: N
BURDICK MEDIC 5 DEFIBNRILLATOR
MDR report key: 585472
·
Received March 24, 2005
Report
- Report Number
- 2112020-2005-00001
- Event Type
- Death
- Date Received
- March 24, 2005
- Date of Event
- February 23, 2005
- Report Date
- March 21, 2005
- Manufacturer
- QUINTON CARDIOLOGY, INC. (BURDICK PRODUCTS
- Product Code
- LDD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A STRESS TEST A PT WENT INTO V-TAC, THE DOCTOR CHARGED UP THE MEDIC 5 DEFIBRILLATOR WHICH FAILED TO DISCHARGE. THE PT WAS TRANSPORTED TO THE HOSP IN CARDIAC ARREST. DURING LATER ATTEMPTS TO CONTACT THE DOCTOR TO ARRANGE TO GET THE UNIT RETURNED FOR EVALUATION, A CONTACT (WHO WISHED TO REMAIN UNKNOWN) AT THE CLINIC INFORMED CO THAT THE PT HAD EXPIRED, BUT WOULD NOT PROVIDE CO THAT THE PT HAD EXPIRED, BUT WOULD NOT PROVIDE CO FURTHER INFORMATION ON THE PT (SEX, AGE, WEIGHT, DATE OF DEATH, PRE-EXISTING MEDICAL CONDITION, ETC.).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BURDICK MEDIC 5 DEFIBNRILLATOR | DEFIBRILLATOR/MONITOR | LDD | QUINTON CARDIOLOGY, INC. (BURDICK PRODUCTS | MEDIC 5 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |