AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER
Report
- Report Number
- 3013421741-2023-00035
- Event Type
- Injury
- Date Received
- July 6, 2023
- Date of Event
- June 2, 2023
- Report Date
- June 18, 2023
- Manufacturer
- VYAIRE MEDICAL INC.
- Product Code
- CAI
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED YET.
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE CUSTOMER REPORTED THAT THEY HAVE A FAULTY CSC100 AIRLIFE VERSO AIRWAY ACCESS ADAPTER. HERE IS THE HIGH-LEVEL REPORT. WE ARE WAITING ON MORE DETAIL. · WE HAD A BROKEN IN-LINE SUCTIONING PIECE AND ONE OF THE BROKEN PIECES OBSTRUCTED THE PATIENT'S AIRWAY. · WE KEPT THE BROKEN PARTS TO SEND BACK TO THE MANUFACTURER. · NORMALLY THIS IS ALL PACKAGED AND ALL INTACT. THE NURSE WAS CALLED INTO THE ROOM BECAUSE THE VENT WAS ALARMING. SHE HEARD AN AIR LEAK AND SAW THIS SECTION BROKEN. ... TIDALING AND OBSTRUCTING THE AIRWAY. ...]THE VENT WAS ALARMING FOR AIRWAY OBSTRUCTION. SINCE THERE WAS AN ADVERSE EVENT INVOLVING PATIENT USE A REPORT WAS SUBMITTED TO MEDWATCH (MDW-003853) - SEE ISSUE BACKGROUND FILES. PATIENT AIRWAY WAS OBSTRUCTED BUT IT WAS ABLE TO BE CAUGHT AND RESOLVED QUICKLY. RETURNED PRODUCT WAS SENT TO C.G. LABORATORIES FOR DECONTAMINATION PRIOR TO SHIPPING TO AIRLIFE GRAND RAPIDS. PRODUCT WAS SHIPPED TO (B)(6) HOSPITAL SUPPLY ON SEP-23.
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE CUSTOMER REPORTED THAT THEY HAVE A FAULTY CSC100 AIRLIFE VERSO AIRWAY ACCESS ADAPTER. HERE IS THE HIGH-LEVEL REPORT. WE ARE WAITING ON MORE DETAIL. · WE HAD A BROKEN IN-LINE SUCTIONING PIECE AND ONE OF THE BROKEN PIECES OBSTRUCTED THE PATIENT'S AIRWAY. · WE KEPT THE BROKEN PARTS TO SEND BACK TO THE MANUFACTURER. · NORMALLY THIS IS ALL PACKAGED AND ALL INTACT. THE NURSE WAS CALLED INTO THE ROOM BECAUSE THE VENT WAS ALARMING. SHE HEARD AN AIR LEAK AND SAW THIS SECTION BROKEN. ... TIDALING AND OBSTRUCTING THE AIRWAY. ...]THE VENT WAS ALARMING FOR AIRWAY OBSTRUCTION. SINCE THERE WAS AN ADVERSE EVENT INVOLVING PATIENT USE A REPORT WAS SUBMITTED TO MEDWATCH (MDW-003853) - SEE ISSUE BACKGROUND FILES. PATIENT AIRWAY WAS OBSTRUCTED BUT IT WAS ABLE TO BE CAUGHT AND RESOLVED QUICKLY. RETURNED PRODUCT WAS SENT TO C.G. LABORATORIES FOR DECONTAMINATION PRIOR TO SHIPPING TO AIRLIFE GRAND RAPIDS. PRODUCT WAS SHIPPED TO PACIFIC HOSPITAL SUPPLY ON SEP-23. THERE IS ONE CAPA (CAPA-000001138) FOR THE COMPLAINT, NOW THE CROSS TEAM (ENGINEERING, SUPPLIER QUALITY, PURCHASE AND SOURCING TEAM) WORK TOGETHER WITH SUPPLIER AOK ON THE COMPLAINT ROOT CAUSE ANALYSIS AND ACTION VALIDATION PROCESS.
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CSC100 ADAPTER VERSO AIRWAY ADULT/PED 20/BX HAS A BROKEN PIECES THAT OBSTRUCTED THE PATIENT¿S AIRWAY.AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CSC100 ADAPTER VERSO AIRWAY ADULT/PED 20/BX HAS A BROKEN PIECES THAT OBSTRUCTED THE PATIENT'S AIRWAY.AT (HTTP-S:LLAIRWAY.AT). THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CSC100 ADAPTER VERSO AIRWAY ADULT/PED 20/BX HAS A BROKEN PIECES THAT OBSTRUCTED THE PATIENT'S AIRWAY.AT (HTTP-S:LLAIRWAY.AT). THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1775705 | AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | CAI | VYAIRE MEDICAL INC. | CSC100 | 22012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |