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

Model Number V60 V60PLUS VENTILATOR

Device Problem Power Problem (3010)

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

Event Date 12/17/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the power cord was disconnected.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.In a good faith effort (gfe) response received from the philips operational planner, it was clarified that the power cord which was replaced was torn and the innermost conducting wires were exposed.The field service engineer (fse) replaced the power cord.The device then passed function testing and a running test.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

The replaced power cord was returned to the philips product investigaton lab (pil) for evaluation.The pil technician verified through visual inspection of the part that the power cord was damaged in the way of exposed wiring.The outer sheath and the white wire were damaged.The pil technician stated that the damage was a result of an occurrence that extends beyond the physical limitations of the power cord.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: 18494272
• MDR Text Key: 332677964
• Report Number: 2518422-2024-02000
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 884838033832
• UDI-Public: (01)884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/03/2024
• Date Device Manufactured: 05/18/2017
• 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