FDA Adverse Event
Malfunction
Summary report: N
EFFICIA DFM100
MDR report key: 16782899
·
Received April 21, 2023
Report
- Report Number
- 3030677-2023-01672
- Event Type
- Malfunction
- Date Received
- April 21, 2023
- Date of Event
- March 24, 2023
- Manufacturer
- PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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
THIS CASE IS FOUND DUPLICATE OF PR 3063601 AS PER INVESTIGATOR¿S CONFIRMATION. THUS PLEASE REFER TO EMDR REPORT(MFR REPORT NUMBER: 3030677-2023-01231) FOR FURTHER DETAILS.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE DEVICE DOES NOT WORK PROPERLY. SPECIFIC MALFUNCTION IS CURRENTLY UNKNOWN, AND REQUEST HAS BEEN SENT OUT FOR SUCH INFORMATION. THERE WAS NO PATIENT INVOLVEMENT. 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 |
|---|---|---|---|---|---|---|---|
| 448099 | EFFICIA DFM100 | XL+DEFIBRILLATOR | MKJ | PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC | 866199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |