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

Model Number V60 V60PLUS VENTILATOR

Device Problems Improper Flow or Infusion (2954); Insufficient Information (3190)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

E: (b)(6).Phone: reporter: (b)(6).

Event Description

Philips received a complaint by the customer on the v60 indicating that there was a high frequency alarm issue.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.Investigation is ongoing.

Manufacturer Narrative

Philips received a complaint by the customer on the v60 indicating that there was a high frequency alarm issue.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that there was a high frequency alarm issue.Per good faith effort (gfe) response, the authorized service provider (asp) engineer was not able to evaluate or repair the device as the customer did not accept the quote.It is unknown what the outcome of the service event was, and no further information could be obtained.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.

• 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: 18940261
• MDR Text Key: 338126336
• Report Number: 2518422-2024-14482
• 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
• Reporter Occupation: Other
• 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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/01/2024
• Date Device Manufactured: 04/04/2017
• 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