FDA Adverse Event
Malfunction
Summary report: N
FIRST SAVE
MDR report key: 278816
·
Received May 18, 2000
Report
- Report Number
- 2132572-2000-00001
- Event Type
- Malfunction
- Date Received
- May 18, 2000
- Date of Event
- April 19, 2000
- Manufacturer
- SURVIVALINK CORP.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WHEN THE LID OF THE AED WAS OPENED AT A RESCUE ATTEMPT, THE PROMPT WAS "SERVICE REQUIRED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIRST SAVE | AUTOMATED EXTERNAL DEFIBRILLATOR (AED) | MKJ | SURVIVALINK CORP. | 9100-001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |