MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; CROSSVENT 2I VENTILATOR

Model Number	CV-2I+
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer could find nothing wrong with the device, after extensive testing.We believe that the user's oxygen tank running out caused the reported condition.As a precautionary measure, we changed the main circuit board in the ventilator, as that circuit board had already served 8 years in the field in transport.
Event or Problem Description
Narration from user of transport ventilator: after 20 minutes on a transport ventilator, 'patient o2 sats dropped.Could not dial in a pip or peep pressure.Could not hear the vent cycling.' patient was then hand-ventilated instead, and there was no injury to the patient.Ventilator was removed from service, and hospital technicians could find nothing wrong.Technicians did notice that one of the supply oxygen tanks taken on the transport was empty.It was suspected that running out of pressurized supply gas may have caused this incident.

• Brand Name: BIO-MED DEVICES
• Common Device Name: CROSSVENT 2I VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 5701969
• Report Number: 1218704-2016-00002
• Device Sequence Number: 8363
• Product Code: CBK
• UDI-Device Identifier: 00813841020805
• UDI-Public: 00813841020805
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K942938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/06/2016

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: Respiratory Therapist
• Device Model Number: CV-2I+
• Device Catalogue Number: 2200IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2016
• Initial Report FDA Received Date: 06/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1