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 02/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the power supply was installed, but the battery was not charging.It was reported that there was no patient involvement at the time the issue was discovered.The v60 was removed from service.The biomedical engineer (bme) called technical support to report that the power supply was installed, but the battery was not charging.The bme also stated that the battery was approximately at 9 volts.The remote service engineer (rse) advised the bme to charge the device for 48 hours, and if the device failed to charge, the rse recommended that the bme should order a replacement battery.The bme informed the rse that the battery is approximately 4 years old, and the rse advised the bme that the battery may have been depleted to a level that it will not recover or function.The rse also provided the bme with the part number for the replacement battery for repair.Resolution and disposition are pending.

Manufacturer Narrative

H10: per good faith effort (gfe) response, the bme confirmed that the battery was not working as it failed to charge and showed under 10 volts in the service screen.A replacement battery was ultimately ordered for repair, and after the battery replacement was performed, the bme verified that the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.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: 18789559
• MDR Text Key: 336346466
• Report Number: 2518422-2024-10028
• 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

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Date Device Manufactured: 04/20/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1