MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	V60
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that there was battery failure.There was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.The device's power management (pm) board was replaced for field change order remediation, and the device alarmed for battery failure.The customer had aftermarket batteries.A good faith effort response was received and battery alarm after pm board replacement and error code 1124 in the device's log history for battery failure was confirmed.The investigation is ongoing.
Additional Manufacturer Narrative
Multiple attempts have been made to try to obtain further information about this case, but no response was received from the customer.The complaint will be processed for closure.If additional information becomes available at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• Brand Name: RESPIRONICS
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 20391106
• Report Number: 2518422-2024-61109
• Device Sequence Number: 7944475
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/16/2025
• Date Device Manufactured: 09/25/2013
• 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