FDA Adverse Event
Malfunction
Summary report: N
SERIES 50A ANTEPARTUM FETAL MONITOR
MDR report key: 12550349
·
Received September 29, 2021
Report
- Report Number
- 9610816-2021-10372
- Event Type
- Malfunction
- Date Received
- September 29, 2021
- Date of Event
- September 15, 2021
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- HFM
- PMA / PMN Number
- K921957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT THE SPEAKER WAS NEEDED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS AUDIO. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO DEATH, OR PATIENT/USER INJURY OR HARM WAS REPORTED.
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SPEAKER WAS NEEDED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS AUDIO. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO DEATH, OR PATIENT/USER INJURY OR HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1443484 | SERIES 50A ANTEPARTUM FETAL MONITOR | SERIES 50A ANTEPARTUM FETAL MONITOR | HFM | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | 862336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |