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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the values given by the device were not correct.It is unknown if the device was in use at the time of the reported problem.No patient or user harm reported.The bench service engineer (bse) evaluated the device at a philips bench repair center.After testing the device, the allegation of measurements being incorrect could not be verified because the bse observed no anomaly with the device.All the measurements observed by the bse were within the acceptable range.Good faith effort (gfe) attempts are being completed to clarify the device use at the time of the reported issue.This investigation is ongoing.

Manufacturer Narrative

E1: (b)(6).

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the bench service engineer (bse) received on 19jan2024, it was stated that the device use at the time of the event remains unknown to them.The investigation is ongoing.

Manufacturer Narrative

H10: it was confirmed the device did not require any further work regarding the allegation of incorrect values being given due to the bse not being able to duplicate the allegation.During the service of the device, the bse did not require any replacement parts for the incorrect values allegation.The bse successfully completed performance verification testing following the service, with the device passing all the required tests.The bse then confirmed that the devices factory settings were restored before returning the device to the customer ready for use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.It remains unknown if the device was in use at the time of the reported problem.No patient or user harm reported.

• 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: 18535911
• MDR Text Key: 333148636
• Report Number: 2518422-2024-03288
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: 00884838009868
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,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
• Device Catalogue Number: 1053615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 02/09/2024
• Supplement Dates FDA Received: 01/19/2024; 02/20/2024
• Date Device Manufactured: 02/15/2016
• 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