AIRLIFE
Report
- Report Number
- 3010838917-2024-00208
- Event Type
- Malfunction
- Date Received
- October 31, 2024
- Date of Event
- September 24, 2024
- Report Date
- December 12, 2024
- Manufacturer
- VYAIRE OY
- Product Code
- BTL
- UDI-DI
- 10190752135697
- PMA / PMN Number
- K093913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31 OCT 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN. THE ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 24068 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 12 DEC 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED, DURING AN ATTEMPT TO DO POSITIVE PRESSURE VENTILATION (PPV) WITH T-PIECE, [THE MEDICAL PROVIDER(S)] COULD NOT GET PRESSURE HIGH ENOUGH TO WORK AND DELIVER PROPERLY TO THE BABY. RESPIRATORY THERAPIST X 2 AND REGISTERED NURSE PRESENT. INSTEAD USED A MANUAL BAGGER AND WORKED ON BABY. THERE WAS A REPORTED DELAY IN CRITICAL CARE; HOWEVER, NO INJURY WAS REPORTED.
IT WAS REPORTED, DURING AN ATTEMPT TO DO POSITIVE PRESSURE VENTILATION (PPV) WITH T-PIECE, [THE MEDICAL PROVIDER(S)] COULD NOT GET PRESSURE HIGH ENOUGH TO WORK AND DELIVER PROPERLY TO THE BABY. RESPIRATORY THERAPIST X 2 AND REGISTERED NURSE PRESENT. INSTEAD USED A MANUAL BAGGER AND WORKED ON BABY. THERE WAS A REPORTED DELAY IN CRITICAL CARE; HOWEVER, NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1981779 | AIRLIFE | T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE | BTL | VYAIRE OY | M1091365VS | 24068 | 10190752135697 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |