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

Model Number V60

Device Problems Volume Accuracy Problem (1675); Failure to Deliver (2338)

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

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

Reporter phone number - (b)(6).

Event Description

Philips received a complaint on the v60 ventilator indicating that tidal volume and the patient trigger were 0.The device was reported to be in use at the time of the reported problem.No patient harm reported.The customer informed the remote service engineer (rse) that the ventilator screen showed that the tidal volume and the patients trigger were 0, so the ventilator was replaced immediately.No further information was provided.This investigation is ongoing.

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the authorized service provider (asp) received on (b)(6) 2023, it was stated that the device diagnostic report (drpt) was not available.The asp stated that the device had not been repaired.The customer was also not able to provide the serial number for the v60 ventilator and did not provide the patient information from the time of the event.In a gfe response from the asp received on (b)(6) 2023, it was stated that there was no service planned by philips because the customer chose to go to a 3rd party for service.No further work was performed by philips.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: 17225162
• MDR Text Key: 318103671
• Report Number: 2518422-2023-14460
• 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

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2023
• 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