FDA Adverse Event
Malfunction
Summary report: N
LIFELINE AED
MDR report key: 1881832
·
Received October 8, 2010
Report
- Report Number
- 3003521780-2010-00018
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- February 7, 2010
- Report Date
- September 9, 2010
- Manufacturer
- DEFIBTECH, LLC
- Product Code
- MKJ
- Removal / Correction Number
- Z-0580-2007, Z-0581-2007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL: THE ELECTRONIC HISTORY FILE FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. BASED ON THE INVESTIGATION, THE SOFTWARE INCORRECTLY CLEARED A LOW BATTERY WARNING, AS ADDRESSED IN RECALL #Z-0580-2007 AND #Z-0581-2007. ALSO, SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS..
Description of Event or Problem · 1
ELECTRONIC USAGE HISTORY FOR A DEVICE WAS RECEIVED FOR A SEPARATE ISSUE ON (B)(6) 2010. A REVIEW OF ITS ELECTRONIC HISTORY RECORD SHOWED THAT ON (B)(6) 2010, THE DEVICE ADVISED A SHOCK, BEGAN TO CHARGE AND THEN CANCELLED THE SHOCK. THE DEVICE THEN REPORTED, A SERVICE MESSAGE AND POWERED OFF. NO PATIENT DETAILS OR OUTCOME ARE AVAILABLE.
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 | Life Threatening |