FDA Adverse Event
Malfunction
Summary report: N
INVIVO CORPORATION
MDR report key: 10017287
·
Received May 1, 2020
Report
- Report Number
- 1051786-2020-00025
- Event Type
- Malfunction
- Date Received
- May 1, 2020
- Report Date
- April 27, 2020
- Manufacturer
- INVIVO CORPORATION
- Product Code
- MWI
- PMA / PMN Number
- K090785
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- 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. H3 OTHER TEXT : THE CUSTOMER STATED THAT HE WAS ABLE TO FIX THE DEVICE ON HIS OWN AND DID NOT REQUIRE INTERVENTION FROM PHILIPS.
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT PROVIDE SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE MONITOR FELL AND DOES NOT WORK ANYMORE. THE CUSTOMER FURTHER REPORTED THAT THE MONITOR IS NOT CRACKED, BUT THE SCREEN REMAINS BLANK AND THE DEVICE DOES NOT START. THE DEVICE WAS NOT IN USE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 480110 | INVIVO CORPORATION | PATIENT MONITOR | MWI | INVIVO CORPORATION | 453564180091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |