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

Model Number V60

Device Problem Battery Problem (2885)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device had a non-proprietary battery in the device, so a field change order could not be implemented.The battery needs replaced.It was reported that there was no patient involvement at the time the issue was discovered.

Manufacturer Narrative

An authorized service provider (asp) was dispatched onsite to evaluate and repair the device.Upon arrival, the asp reviewed the diagnostic report (drpt) and did not find any errors.The asp then replaced the power management (pm) printed circuit board assembly (pcba) to implement a field change order and confirmed that the device successfully passed the required performance verification tests per philips standard.The asp also verified that the device was returned to service and ready for patient use.

• 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: 18450374
• MDR Text Key: 332171985
• Report Number: 2518422-2024-00783
• Device Sequence Number: 1
• Product Code: MNT
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2024
• Date Device Manufactured: 03/27/2017
• 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