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

Model Number V60

Device Problem Device Emits Odor (1425)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a burning smell following a part replacement.The device was reported to be outside of use at the time of the reported problem.There was no patient or user harm reported.The customer informed the remote service engineer (rse) that after replacing a blower assembly, the device began producing a burning smell.The customer was advised by the rse to check the motor controller (mc) printed circuit board assembly (pcba) and data acquisition (da) pcba for anything that could be tarnished.The customer emailed back stating that they found evidence of the da pcba overheating and damaged.The rse provided the customer with the replacement part information for the da pcba and the da to mc pcba cable.This investigation is ongoing.

Manufacturer Narrative

The customer was confirmed to have attempted to replace the recommended parts, but due to improper installation it was determined and recommended that the customer needed to reorder the da pcba and da to mc pcba cable.Multiple good faith efforts (gfe) were attempted to obtain confirmation of the part order, part replacement, and resolution.No response or further information was received from the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened and a supplemental report will be submitted.

• 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: 17846626
• MDR Text Key: 324633951
• Report Number: 2518422-2023-25052
• 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: 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: 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: 09/11/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/13/2023
• Date Device Manufactured: 09/18/2013
• 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