FDA Adverse Event
Malfunction
Summary report: N
IMPACT 73X PORTABLE VENTILATOR SYSTEM
MDR report key: 4178526
·
Received October 16, 2014
Report
- Report Number
- 2242630-2014-00002
- Event Type
- Malfunction
- Date Received
- October 16, 2014
- Date of Event
- November 18, 2013
- Report Date
- July 30, 2014
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- BTL
- PMA / PMN Number
- K051476
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 EVALUATION OF THE IT WAS DETERMINED THAT THE PRESSURE RELIEF VALVE WAS OPERATING AT A LEVEL BELOW THE SPECIFIED OPERATIONAL LIMITS. ADDITIONALLY, THE CHECK VALVE INDICATED THAT IS WAS LEAKING, THOUGH JUST BELOW THE OPERATIONAL LIMITS, AND WAS REPLACED TO PREVENT SYSTEM FAILURE. THIS SYSTEM HAD NO PRIOR IMPACT INSTRUMENTATION, INC. PREVENTATIVE MAINTENANCE PERFORMED. THIS SYSTEM IS 5 YEARS AND 10 MONTHS OLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659638 | IMPACT 73X PORTABLE VENTILATOR SYSTEM | VENTILATOR | BTL | IMPACT INSTRUMENTATION, INC. | 73X | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE REPORTED BY THE OPERATOR |