FDA Adverse Event
Death
Summary report: N
LIFELINE AED
MDR report key: 2023178
·
Received February 15, 2011
Report
- Report Number
- 3003521780-2011-00005
- Event Type
- Death
- Date Received
- February 15, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 14, 2011
- Manufacturer
- DEFIBTECH, LLC
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE END CUSTOMER REPORTED, THE DEVICE REPORTED A LOW BATTERY WARNING DURING USE. NEITHER THE DEVICE NOR THE ELECTRONIC HISTORY RECORD HAS BEEN RETURNED TO ASSIST WITH THE INVESTIGATION. ADD'L ATTEMPTS WILL BE MADE AND A F/U MDR WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
ON (B)(4) 2011, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE REPORTED A LOW BATTERY WARNING. THE PT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFELINE AED | SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR | MKJ | DEFIBTECH, LLC | DDU-100A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |