FDA Adverse Event
Malfunction
Summary report: N
EFFICIA DFM100
MDR report key: 21677930
·
Received March 24, 2025
Report
- Report Number
- 3030677-2025-000943
- Event Type
- Malfunction
- Date Received
- March 24, 2025
- Date of Event
- February 28, 2025
- Report Date
- March 31, 2025
- Manufacturer
- PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
- Product Code
- MKJ
- UDI-DI
- 00884838057975
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT WAS DISCOVERED TO BE A DUPLICATE OF (B)(4) SUBMITTED AS MDR NUMBER 3030677-2025-000729.
Description of Event or Problem · 0
PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 DEVICE INDICATING THAT THE ECG WAS NOT WORKING. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL # 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL # 861290.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740169 | EFFICIA DFM100 | RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. | 866199 | 00884838057975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |