VYAIRE MEDICAL, INC.
Report
- Report Number
- 8030673-2025-00011
- Event Type
- Malfunction
- Date Received
- May 8, 2025
- Date of Event
- November 17, 2025
- Report Date
- June 30, 2025
- Manufacturer
- VYARIE MEDICAL
- Product Code
- LSZ
- UDI-DI
- 0150190752159745
- PMA / PMN Number
- P890057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- 003
Narratives
H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) INVESTIGATION FINDINGS: UNEXPECTED OR RANDOM COMPONENT FAILURE RELATED TO THE DESIGN. H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) INVESTIGATION CONCLUSION: UNEXPECTED OR RANDOM COMPONENT FAILURE RELATED TO THE DESIGN. ANALYSIS OF PHOTOGRAPHIC EVIDENCE CONFIRMED THE CIRCUIT DISCONNECTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS REPORTED EVENT IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; HOWEVER, A SAMPLE OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. BASED ON THE ABOVE THE ROOT CAUSE WAS ESTABLISHED TO BE DESIGN RELATED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED ALL INFORMATION REASONABLY KNOWN AS OF 08 MAY 2025 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 FOLLOWING INITIAL FDA REPORT WAS SUBMITTED FOR THIS EVENT ON 25MAR2025_CI1742939153231.9620678@FDSAHL88CEB438_TE2 AND CI1742937403264.12789009@FDSAHL86CEB429_TE1.
UPON FURTHER REVIEW: IT HAS BEEN DETERMINED, BASED ON THE MANUFACTURING AGREEMENT, AIR LIFE IS ONLY THE CONTRACT MANUFACTURER FOR THE DEVICE (PRODUCT CODE 29028-003) WHICH WAS REPORTED IN THIS COMPLAINT AND IS THEREFORE NOT RESPONSIBLE FOR REGULATORY REPORTING TO ANY COMPETENT AUTHORITY OR NOTIFIED BODY. NO ADDITIONAL REPORTS WILL BE SUBMITTED CONCERNING THE REPORTED EVENT BY AIR LIFE (A DIVISION OF SUN MED HOLDINGS LLC). ALL INFORMATION REASONABLY KNOWN AS OF 30 JUN 2025 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 (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 A SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED: SENSORMEDICS 3100B OSCILLATOR STOPPED OSCILLATING AND LOST PRESSURE WHILST ON [THE] PATIENT. [THE] PATIENT [WAS] IMMEDIATELY HAND VENTILATED BY NURSE, NURSE SHOUTED FOR HELP WHERE MEDICAL, NURSING AND TECHNICAL TEAM ATTENDED. TECH NOTICED CIRCUIT HAD DISCONNECTED NEAR THE HUMIDIFIER CHAMBER (CIRCUIT THAT HAD DISCONNECTED WAS AT THE POINT WHERE THE WHITE CABLE TIE WAS ATTACHED BY THE MANUFACTURER BUT HAD NOT HELD CIRCUIT TOGETHER) AND REINSERTED CIRCUIT, HOWEVER NOTICED THAT THE CIRCUIT AT THE DISCONNECTION ITSELF WAS EXTREMELY PLIANT AND WARM. ONCE RECONNECTED, RE-ESTABLISHED PRESSURE AND RE-CONNECTED TO PATIENT. CIRCUIT KEPT HELD TOGETHER BY HAND AS UNSURE THIS WOULD REMAIN ATTACHED THEREFORE TECH ATTACHED TWO ADDITIONAL CABLE TIES TO ENSURE THIS WAS SECURE. TECH UNHAPPY THAT THIS WOULD NOT REMAIN ATTACHED DUE TO THE CONDITION OF THE CIRCUIT THEREFORE AFTER DISCUSSION, DECIDED TO ELECTIVELY CHANGE TO NEW SENSORMEDICS 3100B IMMEDIATELY.
IT WAS REPORTED: SENSORMEDICS 3100B OSCILLATOR STOPPED OSCILLATING AND LOST PRESSURE WHILST ON [THE] PATIENT. [THE] PATIENT [WAS] IMMEDIATELY HAND VENTILATED BY NURSE, NURSE SHOUTED FOR HELP WHERE MEDICAL, NURSING AND TECHNICAL TEAM ATTENDED. TECH NOTICED CIRCUIT HAD DISCONNECTED NEAR THE HUMIDIFIER CHAMBER (CIRCUIT THAT HAD DISCONNECTED WAS AT THE POINT WHERE THE WHITE CABLE TIE WAS ATTACHED BY THE MANUFACTURER BUT HAD NOT HELD CIRCUIT TOGETHER) AND REINSERTED CIRCUIT, HOWEVER NOTICED THAT THE CIRCUIT AT THE DISCONNECTION ITSELF WAS EXTREMELY PLIANT AND WARM. ONCE RECONNECTED, RE-ESTABLISHED PRESSURE AND RE-CONNECTED TO PATIENT. CIRCUIT KEPT HELD TOGETHER BY HAND AS UNSURE THIS WOULD REMAIN ATTACHED THEREFORE TECH ATTACHED TWO ADDITIONAL CABLE TIES TO ENSURE THIS WAS SECURE. TECH UNHAPPY THAT THIS WOULD NOT REMAIN ATTACHED DUE TO THE CONDITION OF THE CIRCUIT THEREFORE AFTER DISCUSSION, DECIDED TO ELECTIVELY CHANGE TO NEW SENSORMEDICS 3100B IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730330 | VYAIRE MEDICAL, INC. | FLEXIBLE PATIENT CIRCUIT, 3100A MR850 IN HEATED ENVIRONMENT | LSZ | VYARIE MEDICAL | 29028-003 | UNKNOWN | 0150190752159745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |