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

Model Number	V60
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer, reporting that the v60 ventilator was not turning on.There was no patient involvement when the issue occurred.There was no patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator was not turning on.The biomedical engineer (bme) stated that the device would not turn on.The bme then determined that the battery was drained, and the device was not operating on alternating current (ac) power.The battery was replaced, and the device was able to power on.It was then noted that the device powered down, due to operating on battery.During troubleshooting, the rse provided instructions to the customer per the service manual.The bme confirmed that the power supply was bad.The customer was provided with the part number for a replacement power supply.
Additional Manufacturer Narrative
H10 insufficient information is available to determine the resolution of the event.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.H11 d4 - product udi.

• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19620288
• Report Number: 2518422-2024-39992
• Device Sequence Number: 6433992
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/25/2024

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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 06/06/2011
• 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