FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 5503875
·
Received March 16, 2016
Report
- Report Number
- 2031642-2016-00656
- Event Type
- Malfunction
- Date Received
- March 16, 2016
- Report Date
- February 23, 2016
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE: THE FAILURE OF C56 PREVENTED THE POWER SUPPLY FROM OPERATING ON AC POWER. (B)(4). THE MMI BOARD AND MAIN BOARD WERE TESTED AND NO FAILURES WERE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE FAILING TO ALARM DURING AN ALARM CONDITION. NO PATIENT INVOLVEMENT .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162131 | ESPRIT VENTILATOR | VENTILATOR | CBK | RESPIRONICS CALIFORNIA, INC | V1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |