MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; CROSSVENT VENTILATOR

Model Number	2200IC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This ventilator was returned to the manufacturer for examination as a precaution.The manufacturer inspected the ventilator, and performed extended observation, including continuously running the ventilator for one week.No device problems were found (no insufficiency in output, no ventilation stoppages, and all alarms functional).The manufacturer concludes that the field problem most likely resulted from a source-gas issue, perhaps involving the switching mechanism between wall and tank inputs.
Event or Problem Description
User narrative: "this vent is used on our transport stretcher.A therapist went to pick up an intubated baby.While he was in the referring hospital, he placed the baby on the crossvent with the air and oxygen hooked to the wall.Baby was fine.He swapped gases to the tanks and took the baby to the ambulance.Once he got on the ambulance the baby began to desat, chest movement decreased, and poor breath sounds noted.He had to gases hooked to the wall outlet of the ambulance.Both cylinders on the ambulance were full.Et tube was confirmed in place.They took the baby off the vent and bagged.The sats came up and the breath sounds were good.He put the baby back on the vent and within a couple of mins the same scenario happened, desat, poor breath sounds and decreased chest movement.He ended up bagging the baby for the remainder of the transport.He said the vent was showing the set pip and peep.Nothing looked off on the vent screen.Once he got back, we left the circuit on and tried to troubleshoot.We placed a test lung and started the vent.Nothing looked out of place.The test lung held the peep and it was noticeable when a breath was delivered.You could take the test lung off and feel the flow.The vent showed pip and peep readings like nothing was wrong.He was adamant that the vent was not delivering the pressure.The only thing i could find that may or may not have had an impact is that he had the valve switches for the air and oxygen turned "on" to the tanks even when he was connected to the wall source.We are not 100% sure if the vent was functional or if it was user error at some point so we decided to send it back to make sure it was ok for use.".

• Brand Name: BIO-MED DEVICES
• Common Device Name: CROSSVENT VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer (Section G): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer Contact: ken close ; 61 soundview rd; guilford, CT 06437 ; 2034580202
• MDR Report Key: 22088473
• Report Number: 1218704-2025-00002
• Device Sequence Number: 7885979
• Product Code: CBK
• UDI-Device Identifier: 00813841020805
• UDI-Public: 00813841020805
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2200IC
• Device Catalogue Number: 2200IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown