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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Charge (1085)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

G1 contact office phone: (b)(6).

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a battery that was not charging, and the fan was not cycling.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a battery that was not charging, and the fan was not cycling.The customer reported that the ventilator was not charging the battery, and the fan is turning on and off every four seconds.The customer verified that there was 24 dc (direct current) volts from the power supply, to the power management (pm) board.The customer reported that the battery was reading at 13.2 volts; it was then noted that the device was in a trickle charge mode.The rse advised the customer to have the battery charging for more than a few hours.During troubleshooting, the customer was advised to check the terminals on the battery connection; the customer then reported that one of the terminals had been pulled in.The customer then corrected the issue, and the device was charging, and the fan was running steady.The rse followed up with the customer the next, day and it was reported that the battery voltage was at 16.67 volts.The customer also ran a battery test, and the device passed.

• 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: 19079945
• MDR Text Key: 339830958
• Report Number: 2518422-2024-18706
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 11/20/2017
• 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