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 06/27/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that during patient setup, the device did not show that the battery was charging and was not working on alternating current (ac) power when plugged into the outlet.It was reported that there was no patient involvement at the time the issue was discovered.The customer informed the rse that the power light emitting diode (led) was illuminated, but the battery led was not illuminated with the battery connected.The customer also stated that the device operated on battery power only, the power cord was working properly at 120vac at the power cord and ac inlet, and there was no voltage at j1 of power supply.The rse advised the customer to replace the power supply to correct the reported issue and provided the customer with the part number and price of the replacement power supply for repair.

Manufacturer Narrative

Multiple attempts have been made to try to obtain further information about this case, but no response was received from the customer.This file is closed and can be reopened if new information becomes available.

• 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: 17277187
• MDR Text Key: 318567621
• Report Number: 2518422-2023-15036
• 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: 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: 06/27/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/25/2023
• Date Device Manufactured: 11/12/2012
• 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