FDA Adverse Event
Malfunction
Summary report: N
INVIVO CORPORATION
MDR report key: 9910846
·
Received April 1, 2020
Report
- Report Number
- 1051786-2020-00020
- Event Type
- Malfunction
- Date Received
- April 1, 2020
- Report Date
- March 25, 2020
- Manufacturer
- INVIVO CORPORATION
- Product Code
- DQA
- UDI-DI
- 00884838084476
- PMA / PMN Number
- K103700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
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 DEVICE WAS NOT PRODUCING ANY SOUND. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 372951 | INVIVO CORPORATION | PATIENT MONITOR | DQA | INVIVO CORPORATION | 453564198611 | 00884838084476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |