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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that the device would not power on unless it was plugged into alternating current (ac) power.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.The biomedical engineer (bme) reported that the device would not power on unless it was plugged into alternating current (ac) power.The reported issue was confirmed as the battery was more than 5 years old based on the date of manufacturing and needed to be replaced.A replacement battery was therefore ordered for repair.The replacement of the battery is aligned to the periodic maintenance procedure specified in the v60 service manual which indicates that the battery requires replacement every 5 years to ensure proper system performance.

Manufacturer Narrative

H10: there was no patient involvement at the time the issue was discovered.Upon receiving the new battery, the bme performed the battery replacement, verified that the battery was charging correctly, and successfully ran performance verification testing.The bme verified that the issue was resolved, and the device 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
• Type of Device: 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18940444
• MDR Text Key: 338128307
• Report Number: 2518422-2024-14481
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/03/2024
• Date Device Manufactured: 03/19/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1