FDA Adverse Event
Other
Summary report: N
HEARTSTART
MDR report key: 702731
·
Received April 21, 2006
Report
- Report Number
- 9610483-2006-00083
- Event Type
- Other
- Date Received
- April 21, 2006
- Date of Event
- April 27, 2000
- Report Date
- May 4, 2000
- Manufacturer
- LAERDAL MEDICAL A.S.
- Product Code
- NKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN INCIDENT IN 2000 INVOLVING A PATIENT THIS DEFIBRILLATOR ANALYZED, STARTED TO CHARGE AND THEN SHUT DOWN PROMPTING "BATTERY ???" (NOT SURE OF THE EXACT PROMPT). A SECOND BATTERY WAS TRIED AND THE SAME THING HAPPENED 6 TIMES, THE UNIT SHUT DOWN WITH A PROMPT. A COUPLE OF TIMES THEY SAW A "SERVICE MANDATORY" MESSAGE. ALS ARRIVED AND SHOCKED THE PATIENT. THE PATIENT WAS PRONOUCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART | SAED | NKJ | LAERDAL MEDICAL A.S. | HS2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |