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

Model Number V60

Device Problems Defective Alarm (1014); Insufficient Information (3190)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

E: (b)(6).

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a startup error.There was no patient involvement when the issue occurred.No patient or user harm reported.Investigation is ongoing.

Manufacturer Narrative

H10: a philips service engineer (pse) evaluated the device, and reported that the device had an error, and that the alarm light was faulty.The pse restarted the device, and the problem persisted after reconnecting the alarm light switch.The se noted that the power switch overlay was replaced to resolve the issue.The device was returned to service.

• 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: 18222702
• MDR Text Key: 329575398
• Report Number: 2518422-2023-32176
• 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 Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 11/30/2023
• Date Device Manufactured: 03/06/2013
• 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