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

Model Number V60

Device Problem Device Sensing Problem (2917)

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

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

G: phone: (b)(4).

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device was not staying in standby.There was no patient involvement at the time the issue was discovered.The device was removed from service, but there was not any adverse outcome to patient care or therapy.

Manufacturer Narrative

The biomedical engineer (bme) called technical support to report that the device was not staying in standby.The remote service engineer (rse) informed the bme that the latest version of the service manual is version t, advised the bme of a possible flow sensor problem, and provided the bme with the part number of the replacement flow sensor assembly for repair.Additionally, the rse advised the customer to complete preventive maintenance (pm) and test the device for the correct air flow specifications.Per initial good faith effort (gfe) response, the bme stated that the ventilator simply would not go into standby mode, and the mask self-test would fail each time-- this was not the case for the other devices.The bme ultimately ordered the flow sensor assembly for repair/replacement.Per follow-up gfe response, the bme performed the flow sensor assembly replacement and verified that the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19197435
• MDR Text Key: 341240740
• Report Number: 2518422-2024-23004
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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 Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 06/06/2012
• 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