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

Model Number V60

Device Problem No Audible Alarm (1019)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

H10: a philips authorized service provider (asp) evaluated the device and determined that the speakers were bad.The asp replaced the speakers.The device was operational returned units back to service after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H11:updated contact information, contact office entity, and manufacturing site.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00096.All information from the original report(s) has been transferred to this report.

Event Description

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint from customer biomed reporting an error message indicating a primary alarm failure on a v60 ventilator.The device was not in clinical use.There was no report of patient/user harm.A review of the risk management file was performed and it was determined that this complaint is a reportable malfunction.Regulatory reports have been submitted per regulations.A philips remote service engineer (rse) evaluated the issue with the customer.The customer verified code 1102 (primary alarm failed) in the significant log.The rse recommended replacement of the speakers which aligns with the recommended repair of the reported malfunction per the service manual.

• 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: 17386257
• MDR Text Key: 319699107
• Report Number: 2518422-2023-16653
• 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

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: 12/14/2022
• Initial Date FDA Received: 07/24/2023
• Date Device Manufactured: 11/06/2018
• 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