FDA Adverse Event
Malfunction
Summary report: N
LIFELINE
MDR report key: 19198363
·
Received April 26, 2024
Report
- Report Number
- 3003521780-2024-00374
- Event Type
- Malfunction
- Date Received
- April 26, 2024
- Report Date
- March 27, 2024
- Manufacturer
- DEFIBTECH LLC
- Product Code
- MKJ
- UDI-DI
- 10815098020000
- PMA / PMN Number
- P160032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
TROUBLESHOOTING OF THE AED WITH THE CUSTOMER IDENTIFIED THAT THE AED IS FUNCTIONING AS DESIGNED AND CAN STAY IN SERVICE. TROUBLESHOOTING OF THE AED WITH THE CUSTOMER DID NOT IDENTIFY A CAUSE FOR THE DEPLETED BATTERY PACK. AS A FOLLOW UP WITH THE CUSTOMER, THE PROPER MAINTENANCE OF THIS DEVICE WAS REVIEWED.
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS BLANK, AND IT WILL NOT POWER ON. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878876 | LIFELINE | AUTOMATED EXTERNAL DEFIBRILATOR | MKJ | DEFIBTECH LLC | DDU-100 | 10815098020000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |