MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; MVP-10 VENTILATOR

Model Number	MVP-10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer could find nothing wrong with the device.When we put it through calibration testing in february, we had not been informed of any malfunction.We only became aware of this incident report because the fda forwarded the user facility's mdr report to us.The nature of the narrative leads us to believe that the transport team ran out of compressed gas to power this pneumatic ventilator.We do not believe that the ventilator itself malfunctioned.
Event or Problem Description
Narration from user of transport ventilator: see (b)(4) for full details.After 30 minutes of ventilation, the ventilator stopped supplying a pressure cycle."the patient was quickly transitioned to hand ventilation without difficulty.".

• Brand Name: BIO-MED DEVICES
• Common Device Name: MVP-10 VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 5736201
• Report Number: 1218704-2016-00003
• Device Sequence Number: 3085
• Product Code: CBK
• UDI-Device Identifier: 00813841020898
• UDI-Public: 00813841020898
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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: MVP-10
• Device Catalogue Number: 2010IB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2016
• Initial Report FDA Received Date: 06/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 DA