FDA Adverse Event
Malfunction
Summary report: N
IMPACT 73X PORTABLE VENTILATOR SYSTEM
MDR report key: 4283434
·
Received November 21, 2014
Report
- Report Number
- 2242630-2014-00009
- Event Type
- Malfunction
- Date Received
- November 21, 2014
- Date of Event
- September 29, 2014
- Report Date
- November 6, 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
Narratives
Additional Manufacturer Narrative · 1
THIS SYSTEM WAS SHIPPED IN JANUARY 2009 AND HAS NEVER RECEIVED PERIODIC MAINTENANCE FROM THE MANUFACTURER. THIS SYSTEM WAS MAINTAINED BY THE HOSPITALS CLINICAL ENGINEERING GROUP. THERE WAS INTERNAL DAMAGE TO THE O2 BOARD, SPECIFICALLY R5, AND THIS WAS THE CAUSE OF THE "SYSTEM FAILURE" ALARM.
Description of Event or Problem · 1
THE CUSTOMER ATTEMPTED TO CALIBRATE THIS SYSTEM. THE UNIT WAS POWERED ON - THEN IT EXECUTED A SELF TEST AND ALARMED. THE ALARM WAS FOR A "SYSTEM FAILURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757942 | IMPACT 73X PORTABLE VENTILATOR SYSTEM | VENTILATOR | BTL | IMPACT INSTRUMENTATION, INC. | 73X | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |