MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problem Battery Problem (2885)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter info: (b)(6).

Event Description

Philips received a complaint by the customer on the v60, indicating that there was a battery alarm.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.It was reported that a battery alarm had occurred.This investigation is ongoing.

Manufacturer Narrative

H10: multiple attempts have been made on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024 to try to obtain further information about this case but no response received from the customer.This file is closed and can be reopened if new information becomes available.

• Brand Name: V60 V60PLUS VENTILATOR
• 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: 19034229
• MDR Text Key: 339268308
• Report Number: 2518422-2024-17152
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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 Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/28/2024
• Date Device Manufactured: 09/04/2020
• 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