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

Model Number V60

Device Problem Complete Loss of Power (4015)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer on the v60 ventilator indicating that there were power issues with the device when the device was plugged in.It was showing that it ran on internal battery.There was no patient involvement at the time the issue was discovered.The customer turned the device over to the biomedical engineer (bme) and informed the bme that the device ran on battery and shut down.The customer plugged the device in, and the device was showing that it was properly charging.The customer also left the device plugged in overnight and found that the voltages were showing properly.Additionally, the battery volts were showing 16.3v.The remote service engineer (rse) recommended that the bme should check with staff to find out which room the device was plugged into and verify which outlets were working properly.

Manufacturer Narrative

Per good faith effort (gfe) response, the biomedical engineer mentioned that staff could not remember where the device was plugged in when the issue occurred, but the issue was confirmed through the significant event log.The bme also stated that the issue did not reoccur, but the alternating current (ac) inlet and power cord were replaced for preventive measures as recommended by technical support.The device passed the required performance verification tests per philips standard and was returned to service.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19125302
• MDR Text Key: 340387499
• Report Number: 2518422-2024-20279
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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 Operator: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/18/2024
• Date Device Manufactured: 10/27/2010
• 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