FDA Adverse Event
Malfunction
Summary report: N
PERCUSSIONAIRE VDR4 WITH MONITRON II
MDR report key: 2958744
·
Received January 23, 2013
Report
- Report Number
- 2958744
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 23, 2013
- Manufacturer
- PERCUSSIONAIRE CORPORATION
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE MONITRON II IS AN AIRWAY MONITORING DEVICE THAT WORKS WITH THE VDR4 VENTILATOR. THE MONITRON II SCREEN HAS A HISTORY OF GOING BLANK AND RESETTING. DURING THE RESET PERIOD THE AIRWAY PRESSURE AND WAVEFORMS ARE NOT BEING MONITORED. BOTH OF OUR MONITRON II'S HAVE THE SAME RESET PROBLEM AND HAVE BEEN SENT TO PERCUSSIONAIRE FOR SERVICE. AFTER RETURNING FROM SERVICE THEY WILL STILL RESET DURING USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VENTILATION FOR A CRITICAL PICU PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33078 | PERCUSSIONAIRE VDR4 WITH MONITRON II | VENTILATOR WITH MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND | CBK | PERCUSSIONAIRE CORPORATION | MONITRON II WAVEFORM ANALYZER | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | NO, OTHER DEVICES WOULD NOT HAVE INTERFERED WITH| THIS DEVICE. THIS WAS ON A PICU PATIENT.| NO OTHER THERAPIES |