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

Model Number	CV-2I+
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
Additional Manufacturer Narrative
This ventilator was found to have a substitute battery pack inside, not the manufacturer's own battery pack.This battery pack was manufactured by a company called r&d batteries of burnsville, mn (their part # 6064-nimh).Bio-med devices, the ventilator manufacturer, has no relationship or contact with r&d batteries, and as per the ventilator's ifu, only bio-med devices's battery pack should be used with this ventilator.More specifically, the ventilator's operation & service manual cautions: "only replace the battery pack with bio-med devices part #prt2268.Do not substitute.The cells are non-standard high capacity." the fda might want to visit the deceptive page from r&d batteries' website (https://www.Rdbatteries.Com/6064-nimh) showing their part # 6064-nimh, which might give users the false impression that bio-med devices authorizes r&d batteries' battery pack, via the unauthorized use of bio-med devices' company (& ventilator) name.
Event or Problem Description
User narrative: "needs a pm.Device shut off during transport." no patient injury.Unclear if the ventilator was actually even in use on a patient.

• Brand Name: BIO-MED DEVICES
• Common Device Name: CROSSVENT 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, CT 06437 ; 2034580202
• MDR Report Key: 23373190
• Report Number: 1218704-2025-00005
• Device Sequence Number: 12979353
• Product Code: CBK
• UDI-Device Identifier: 00813841020836
• UDI-Public: 00813841020836
• Combination Product (Y/N): N
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: Health Professional
• Device Model Number: CV-2I+
• Device Catalogue Number: 2200KCB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2016
• 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