FDA Adverse Event
Malfunction
Summary report: N
INVIVO CORPORATION
MDR report key: 1358053
·
Received March 3, 2009
Report
- Report Number
- 1051786-2009-00002
- Event Type
- Malfunction
- Date Received
- March 3, 2009
- Date of Event
- February 4, 2009
- Report Date
- February 4, 2009
- Manufacturer
- INVIVO CORPORATION
- Product Code
- DRT
- PMA / PMN Number
- K040915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS WAITING FOR THE USER FACILITY TO RETURN THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE EVALUATION OF THE DEVICE IN QUESTION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
USER FACILITY REPORTED TO THE MANUFACTURER THAT THE USER WAS NOT RECEIVING ANY ALARM TONES FROM THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVIVO CORPORATION | MAGNITUDE MRI PATIENT MONITORING SYSTEM - REMOTE MONITOR | DRT | INVIVO CORPORATION | 3155MVS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |