FDA Adverse Event
Malfunction
Summary report: N
INVIVO CORPORATION
MDR report key: 8392852
·
Received March 5, 2019
Report
- Report Number
- 1051786-2019-00012
- Event Type
- Malfunction
- Date Received
- March 5, 2019
- Report Date
- February 28, 2019
- Manufacturer
- INVIVO CORPORATION
- Product Code
- DQA
- UDI-DI
- 00884838012585
- PMA / PMN Number
- K103700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT NO ALARM SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186471 | INVIVO CORPORATION | PATIENT MONITOR | DQA | INVIVO CORPORATION | 865353 | 00884838012585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |