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

Model Number V60

Device Problem Failure to Shut Off (2939)

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

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

H10 g - contact office phone number: +1(724) 351-2041 (b)(6).

Event Description

Philips received a complaint from the customer reporting that the v60 ventilator did not turn off per user command.The device was in clinical use.There was no report of harm or other patient impact.The device did not meet specifications for intended use and was removed from service.An alternative ventilator was provided for the patient.The customer reported that the device was unplugged from external power sources and the battery disengaged, then the device power on once power was re-engaged.The customer reported the cause to be a defective power management (pm) printed circuit board assembly (pcba).The investigation is ongoing.

Manufacturer Narrative

A philips authorized service provider (asp) reported that the customer elected to employ a third-party service to complete device repairs.The power management board was replaced to resolve the issue.The customer declined to provide further details.The device was operational and returned to service after repairs were completed.

• 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: 19126787
• MDR Text Key: 340404772
• Report Number: 2518422-2024-20376
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Date Device Manufactured: 01/13/2021
• 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