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

Model Number V60

Device Problem Charging Problem (2892)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the device was alarming.The device was reported to be outside of use, at the time of the reported problem.No patient harm reported.The customer informed the remote service engineer (rse) that the device was alarming low battery and the amber light on the display was not illuminated.The device was only running on the battery.The customer replaced the power cord and the device began to operate on ac power, but the battery still did not charge.Battery voltage was at11.39v and had a 2011 date code.The rse provided the customer replacement part information for the v60 battery.Good faith efforts (gfe) were made to confirm the part order and resolution and a gfe response received on 12jan2023 stated that the customer would order the battery.No further information was provided.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

This report is being submitted as a correction in response to corrective actions taken by the legal manufacturer.The manufacturer site number was incorrectly selected resulting in incorrect report numbers.A new mdr with the correct manufacturer site selected has been submitted under manufacturer report # 2518422-2023-17528.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16219083
• MDR Text Key: 308179484
• Report Number: 2031642-2023-00261
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 07/31/2023
• Date Device Manufactured: 09/01/2011
• 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