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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Read Input Signal (1581)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

H10: e1- initial reporter: (b)(6).

Event Description

Philips received a complaint from the customer reporting the v60 ventilator would not enter standby mode.The device was in clinical use.There was no report of harm.The investigation is ongoing.

Manufacturer Narrative

A philips authorized service provider (asp) evaluated the device and confirmed the device was operating per specifications.No failure was identified.The issue was caused by an application error in using an incompatible patient circuit accessory.Per the v60 user manual, the accessories used during this event are not listed as approved circuits and therefore, not proven to be compatible.The circuit in use may have caused excessive resistance which prevented the device from going into standby.To ensure the correct performance of the ventilator and the accuracy of patient data, the philips v60 user manual recommends to the customer, the use of only respironics-approved accessories with the ventilator.The device was confirmed to be operating per specifications and no failure was identified.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: 17175079
• MDR Text Key: 317754877
• Report Number: 2518422-2023-13943
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089297
• UDI-Public: (01)00884838089297
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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 V60PLUS VENTILATOR
• Device Catalogue Number: 1137292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/15/2023
• Date Device Manufactured: 02/01/2019
• 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