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

Model Number	2200IC
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unit stopped ventilating, with alarms, while on patient.No patient injury.Assumedly, backup ventilation was used.
Additional Manufacturer Narrative
The internal battery pack (1.8 years old) was found to be not holding charge for specified runtime.These batteries should last 2 years in the field, under normal usage conditions.Exact cause of the shortened usable life could not be determined.

• Brand Name: BIO-MED DEVICES
• Common Device Name: CONTINUOUS VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer (Section G): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer Contact: ken close ; 61 soundview rd; guilford 06437 ; 2034580202
• MDR Report Key: 17452209
• Report Number: 1218704-2023-00002
• Device Sequence Number: 17987671
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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
• Device Model Number: 2200IC
• Device Catalogue Number: 2200IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown