FDA Adverse Event
Malfunction
Summary report: N
NICOLET VERSALAB APM/APM2
MDR report key: 9512905
·
Received December 23, 2019
Report
- Report Number
- 3010611950-2019-00078
- Event Type
- Malfunction
- Date Received
- December 23, 2019
- Date of Event
- December 5, 2019
- Report Date
- December 5, 2019
- Manufacturer
- NATUS NEURO INCORPORATED
- Product Code
- LXE
- UDI-DI
- 00382830027885
- PMA / PMN Number
- K010521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REFERENCE (B)(4). CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION LEVEL OF PATIENT INVOLVEMENT AND ADDITIONAL DETAILS OF THE COMPLAINT PROVIDED VIA ADVERSE EVENT QUESTIONNAIRE ON DECEMBER 12 AND DECEMBER 19, 2019. CUSTOMER RETURNED THE QUESTIONNAIRE CONFIRMS THAT NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS PATIENTS WERE REFERRED TO A DIFFERENT SITE FOR TESTING. CUSTOMER WAS ASKED TO CONFIRM ON DECEMBER 23 IF THEY WILL BE ABLE TO RETURN THE PRODUCT TO NATUS FOR ADDITIONAL EVALUATION.
Description of Event or Problem · 1
USER UNABLE TO HEAR FETAL HEARTBEAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1306355 | NICOLET VERSALAB APM/APM2 | VERSALAB APM SINGLE | LXE | NATUS NEURO INCORPORATED | XVLB03 | AVS0105 | 00382830027885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |