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

Model Number	CV-2I+
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Additional Manufacturer Narrative
Battery was almost 7 years old- ifu instructs user to change battery every 2 years.The overall device had never been back to the factory for annual calibration or 2-year pm since 2008.Battery could not hold a charge.
Event or Problem Description
Transport ventilator "turns off while on patients" with alarms sounding.No details on any specific incidents provided by user, and there were no patient injuries.Device was run on battery power.

• Brand Name: BIO-MED DEVICES
• Common Device Name: CROSSVENT VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 5701319
• Report Number: 1218704-2016-00001
• Device Sequence Number: 10801
• Product Code: CBK
• UDI-Device Identifier: 00813841020805
• UDI-Public: 00813841020805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/26/2016

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• 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