REVIVER
Report
- Report Number
- 3003521780-2024-00629
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Report Date
- June 3, 2024
- Manufacturer
- DEFIBTECH LLC
- Product Code
- MKJ
- UDI-DI
- 10815098020222
- PMA / PMN Number
- P160032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
A CUSTOMER REPORTED THEIR AED BATTERY WAS EXPIRED AND THE AED'S ASI WAS BLANK. TROUBLESHOOTING OF THE AED WITH THE CUSTOMER IDENTIFIED THAT THE AED'S BATTERY PACK WAS EXPIRED WITH A LABELED EXPIRATION DATE OF 05/2024. THE CAUSE OF THE BLANK ASI / AED NOT POWERING ON WAS RELATED TO A LACK OF MAINTENANCE OF THE AED. THE CUSTOMER WAS FORWARDED TO A DISTRIBUTOR TO PURCHASE A REPLACEMENT BATTERY PACK. THE IFU STATES: IMPROPER MAINTENANCE CAN CAUSE THE DDU SERIES AEDS NOT TO FUNCTION. MAINTAIN THE DDU SERIES AED ONLY AS DESCRIBED IN THE USER MANUAL AND OPERATING GUIDE. THE AED CONTAINS NO USER-SERVICEABLE PARTS- DO NOT TAKE THE UNIT APART. FOLLOW ALL BATTERY PACK LABELING INSTRUCTIONS. DO NOT INSTALL BATTERY PACKS AFTER THE EXPIRATION DATE. FOLLOW ALL DEFIBRILLATION PAD LABEL INSTRUCTIONS. USE DEFIBRILLATION PADS PRIOR TO THEIR EXPIRATION DATE. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE DEVICE DID NOT PERFORM AS INTENDED, OR FAILED TO MEET PRODUCT SPECIFICATIONS. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MDR SHALL BE SUBMITTED.
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 |
|---|---|---|---|---|---|---|---|
| 526214 | REVIVER | AUTOMATED EXTERNAL DEFIBRILATOR | MKJ | DEFIBTECH LLC | DDU-2300 | 10815098020222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |