FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 7341100
·
Received March 15, 2018
Report
- Report Number
- 2031642-2018-00579
- Event Type
- Malfunction
- Date Received
- March 15, 2018
- Report Date
- November 6, 2017
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MMI PCB ASSEMBLY WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION OF THE MMI PCB ASSEMBLY DID NOT REVEAL ANY SIGNS OF PHYSICAL DAMAGE OR ABUSE. DURING TESTING OF THIS COMPONENT WITH A TEST VENTILATOR, NO OBSERVATIONS OR ERRORS WERE NOTED - ALL TESTING PRODUCED RESULTS THAT WERE WITHIN THE REQUIRED SPECIFICATIONS. THIS MMI BOARD WAS TESTED AND NO FAILURES WERE IDENTIFIED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A VENTILATOR WITH DIAGNOSTIC CODE 3153 (TOUCH SCREEN FAILURE) DURING SERVICING. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184459 | ESPRIT VENTILATOR | VENTILATOR | CBK | RESPIRONICS CALIFORNIA, INC | V1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |