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

Model Number V60

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there were stripped screws which prevented placement on the stand.The device was reported to be outside of use at the time of the reported problem.No patient harm reported.The customer requested the parts id for the white v60 base assembly the remote service engineer (rse) provided to the customer the replacement part information and pricing for the base assembly and advised the customer to replace them.In a good faith effort (gfe) response from the customer received, it was stated that the part had not been ordered yet due to waiting on internal approval for the purchase.The drpt was stated to not be available and there was no plan to return any of the faulty parts.This investigation is ongoing.

Manufacturer Narrative

The customer again responded to a good faith effort attempt stating that the part had not been approved for order yet.The resolution to the device issue will be considered the provision of replacement part information to the customer.Multiple good faith efforts (gfe) were attempted to obtain confirmation of the part replacement and resolution.The investigation concludes that no further action is required at this time.

• 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: 16807461
• MDR Text Key: 313926458
• Report Number: 2518422-2023-09649
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/23/2023
• Date Device Manufactured: 09/14/2018
• 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