FDA Adverse Event
Malfunction
Summary report: N
IMPACT 73X PORTABLE VENTILATOR SYSTEM
MDR report key: 4178510
·
Received October 16, 2014
Report
- Report Number
- 2242630-2014-00004
- Event Type
- Malfunction
- Date Received
- October 16, 2014
- Date of Event
- July 3, 2013
- Report Date
- August 18, 2014
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- BTL
- PMA / PMN Number
- K051476
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
(B)(4). THIS SYSTEM WAS RETURNED TO IMPACT FOR PREVENTATIVE MAINTENANCE. DURING THE PREVENTATIVE MAINTENANCE SERVICE, IT WAS DETERMINED THAT THE OXYGEN REGULATOR WAS NOT PERFORMING TO SPECIFICATION, NOT HOLDING THE TIDAL VOLUME. THE O2 REGULATOR WAS REPLACED AND THE SYSTEM RETESTED AND FUNCTIONS NORMALLY. THIS SYSTEM WAS NOT SEEN BY IMPACT II FOR RECOMMENDED ANNUAL MAINTENANCE PRIOR TO THIS RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658331 | IMPACT 73X PORTABLE VENTILATOR SYSTEM | VENTILATOR | BTL | IMPACT INSTRUMENTATION, INC. | 73X | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | NONE REPORTED BY THE OPERATOR |