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

Model Number V60

Device Problems Defective Alarm (1014); Failure to Sense (1559)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting the v60 ventilator generated an abnormal alarm and buzzing sound when powered on prior to use.The device was reported to be in clinical use but there was no report of harm.The device was exchanged for an alternative ventilator.There was no resulting patient impact.The device did not meet specification for intended use and was removed from service.Investigation ongoing.

Manufacturer Narrative

(b)(6).Hospital (shanxi academy of medical sciences) phone: (b)(6).

Manufacturer Narrative

H10: philips received a complaint from the customer reporting the v60 ventilator generated an abnormal alarm and buzzing sound when powered on prior to use.The device was reported to be in clinical use but there was no report of harm.The device was exchanged for an alternative ventilator.There was no resulting patient impact.The device did not meet specification for intended use and was removed from service.Details regarding the specific alarm, type of alarm tone, and related diagnostic codes generated at the time of the event were requested from the customer but not provided.However, based on details obtained from a philips authorized service provider (asp), the alarm generated was determined to be a patient disconnect alarm and found to be due to a poorly sealed mask and breathing line.The asp reported the issue was found during set-up and not during use, as originally reported.The issue was resolved when the customer biomedical technician properly connected the mask and breathing line to the ventilator.No part replacement was necessary.This issue was due to use error; the device alarm appropriately given the conditions and returned to normal functions once the user adjustments were made.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: 18827058
• MDR Text Key: 336867661
• Report Number: 2518422-2024-11264
• 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 Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/07/2024
• Date Device Manufactured: 04/02/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1