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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Charge (1085)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

Philips received a complaint from a philips medical device maintenance specialist (mdms) reporting the battery on the v60 ventilator could not charge.The device was not in clinical use.There was no report of harm.The mdms evaluated the device for field change order service activity and identified the battery would not charge.The mdms confirmed there was no battery failed alarm and the battery was older than 5 years of age.Per the philips v60 service manual, recommended timetable for battery replacement is every 5 years.The battery replacement is based on the date of manufacture recorded on the battery label.Also, the mdms reported the customer stored the unit without being connected to an alternating current (ac) power source.The v60 service manual advises the user the battery may fail to charge if stored for an extended period of time without the ventilator plugged into ac power.This issue was caused by use error.The mdms confirmed the battery would be replaced once it was made available.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

A source system update confirmed the necessary repair activity was successfully performed.A philips field service engineer (fse) replaced the battery.The device was operational and returned to service after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18049746
• MDR Text Key: 327153503
• Report Number: 2518422-2023-28487
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

• Date FDA Received: 11/01/2023
• 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: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Date Device Manufactured: 08/19/2014
• 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