FDA Adverse Event
Malfunction
Summary report: N
EFFICIA DFM100
MDR report key: 16596148
·
Received March 23, 2023
Report
- Report Number
- 3030677-2023-01234
- Event Type
- Malfunction
- Date Received
- March 23, 2023
- Date of Event
- January 10, 2023
- Manufacturer
- PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 0
THERAPY PCA WAS RETURNED TO FAILURE ANALYSIS LAB FOR FURTHER TESTING, THE REPORTED ISSUE "DEVICE FAILED FUNCTIONAL TEST" WAS NOT VERIFIED IN LAB TESTING. THE THERAPY PCA PASSED ALL TESTS DURING OP CHECK AND PERFORMED AS EXPECTED. THEREFORE, THERE IS NO FAULT FOUND (NFF) WITH THIS THERAPY BOARD.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED THE FUNCTION TEST. THERE WAS NO PATIENT INVOLVEMENT. 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 |
|---|---|---|---|---|---|---|---|
| 10699 | EFFICIA DFM100 | XL+DEFIBRILLATOR | MKJ | PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. | 866199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |