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

Model Number	CROSSVENT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal battery pack of the ventilator was found to be five years old, and no longer holding charge for expected run time.The ifu (and the label on the battery itself) tells the user to change this battery every two years.The ventilator was manufactured in 2013, and has never been sent back to the factory for proper pm / service / calibration.
Event or Problem Description
Transport ventilator "is said to have stopped working during patient transport." still trying to obtain incident details.Not clear yet if the ventilator was actually applied to a patient at the time.
Additional Manufacturer Narrative
The internal battery pack of the ventilator was found to be five years old, and no longer holding charge for expected run time.The ifu (and the label on the battery itself) tells the user to change this battery every two years.The ventilator was manufactured in 2013, and had never been sent back to the factory for proper pm / service / calibration.After speaking multiple times to two contact people at the facility, bio-med devices was unable to obtain any more information to fill out the description of the original complaint scenario.No more user contact names were made available to us.The root cause was obvious and straightforward.This is a final report and no more information will be forthcoming (unless requested by fda, of course).
Event or Problem Description
Transport ventilator "is said to have stopped working during patient transport." not clear if the ventilator was actually applied to a patient at the time.There was no patient injury.

• Brand Name: BIO-MED DEVICES
• Common Device Name: TRANSPORT VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• MDR Report Key: 7405605
• Report Number: 1218704-2018-00001
• Device Sequence Number: 13769220
• Product Code: CBK
• UDI-Device Identifier: 00813841020805
• UDI-Public: 00813841020805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Service and Testing Personnel
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Respiratory Therapist
• Device Model Number: CROSSVENT
• Device Catalogue Number: 2200IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/07/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1