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

Model Number V60

Device Problem Failure to Run on Battery (1466)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

G - contact office phone number: (b)(6).E1 - reporter phone number - (b)(6).

Event Description

Philips received a complaint from the customer on the v60 ventilator indicating that there was battery failure.There was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.The remote service engineer (rse) stated that the customer had performed troubleshooting and confirmed that the battery was faulty.The customer then replaced the battery to resolve the issue.The device passed required performance verification tests per philips standards and 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19182707
• MDR Text Key: 341057900
• Report Number: 2518422-2024-22436
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: 00884838009844
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053613
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 04/25/2024
• Date Device Manufactured: 03/26/2013
• 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