MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; 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 01/18/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the battery was not charging all the way.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.The customer biomedical engineer (bme) stated that they had attempted to charge the v60 battery for 24 hours and the battery only charged up to 15.6 volts, not reaching the maximum charging capacity.The customer bme informed the rse that an order for a replacement battery had been placed.In a good faith effort (gfe) response from the customer received, it was confirmed that a replacement battery was ordered, and they were waiting on the part to arrive.This investigation is ongoing.

Manufacturer Narrative

In a good faith effort (gfe) response from the customer received, it was confirmed that the replacement battery was delivered and installed into the device.The customer biomedical engineer (bme) could not provide further information regarding confirmation of the device returning to use, stating that another bme had taken over at the site.The investigation is ongoing.

Manufacturer Narrative

In a good faith effort (gfe) response from the customer received on 25apr2024, it was confirmed that the replacement battery was delivered and installed into the device.The customer biomedical engineer (bme) could not provide further information at that time regarding confirmation of the device returning to use, stating that another bme had taken over at the site.In a gfe response from the bme received on 26apr2024, it was confirmed that the device was working as intended following the battery replacement.The investigation concludes that no further action is required at this time.

• 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: 18668902
• MDR Text Key: 334908865
• Report Number: 2518422-2024-06266
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 04/25/2024; 04/26/2024
• Supplement Dates FDA Received: 05/01/2024; 05/09/2024
• Date Device Manufactured: 12/17/2013
• 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