MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; AIR / OXYGEN BLENDER

Model Number	2003FFB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer verified the observations of the hospital's own clinical engineering technicians ("knob damaged, shaft bent").The face of the device had been significantly impacted, probably from a drop onto a hard floor.The control knob was cracked.The metal control shaft underneath was bent.The knob could not be actuated in a proper circular motion, instead it turned noticeably askew, with contact with the face plate interfering at some rotation points.The manufacturer repaired the device by replacing the control knob, and the entire underlying valve / shaft assembly, then re-calibrating the device.
Event or Problem Description
Blender was pulled out of service when it was determined that the oxygen % output did not match knob set.Hospital clinical engineering found the knob damaged, with shaft bent.Blender was returned to mfr for repair.

• Brand Name: BIO-MED DEVICES
• Common Device Name: AIR / OXYGEN BLENDER
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 6075988
• Report Number: 1218704-2016-00004
• Device Sequence Number: 16560488
• Product Code: MOD
• UDI-Device Identifier: 00813841021192
• UDI-Public: 00813841021192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K925982
• 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): 11/01/2016

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: 2003FFB
• Device Catalogue Number: 2003FFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1