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

Model Number	V60
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the device intermittently switched to battery power and then back to alternating current (ac) power while cycling.It was reported that there was no patient involvement at the time the issue was discovered as the issue occurred during preventive maintenance (pm) service.No patient or user harm was reported.The customer called technical support to report that the device intermittently switched to battery power and then back to alternating current (ac) power while cycling.The customer noted that the battery is a philips battery (dated 2020) and stated that the issue may be due to the fact that the patient outlet is occluded; alternate power cords and ac outlets were tried, and both light emitting diodes (leds) on the front panel were illuminated solid.The customer removed the power supply shroud but could not determine if 110ac volts was present.The remote service engineer (rse) advised the customer on the signal path for ac and dc power and voltage test points per the v60 service manual and instructed the customer to check the pins within all connectors for seating--if all power sources are good, the rse informed the customer that the central processing unit (cpu) printed circuit board assembly (pcba) may need to be replaced.The rse also provided the customer with the part number of the replacement cpu pcba for repair.The customer replaced the cpu pcba, programmed the serial number, and installed the option codes.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: 20710493
• Report Number: 2518422-2024-070672
• Device Sequence Number: 18617761
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 11/18/2024

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
• 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: 10/24/2024
• Initial Report FDA Received Date: 11/18/2024
• Date Device Manufactured: 12/11/2010
• 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