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

Model Number V60 V60PLUS VENTILATOR

Device Problem Unexpected Shutdown (4019)

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

Event Date 04/08/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device malfunctioned where the power supply would be lost during use on the patient.The hospital stopped using this device and replaced it with a different ventilator.Several hours later, the device in question suddenly powered on and started operating.They turned the device off.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.No other medical intervention provided to the patient, nor a delay was noted.The authorized service provider (asp) evaluated the device, and it was unclear if some alarms had occurred during the issue.The sales rep confirmed that the device was not powered on and replaced.It with the same model one.The issue was duplicated during a check at the sales office.The investigation is ongoing.

Manufacturer Narrative

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Manufacturer Narrative

After further investigation, the authorized service provider (asp) noted that the cause was that the device became unable to operate on alternating current (ac) power and that the battery longer charged, resulting in loss of power after depletion of the battery.Therefore, the power supply was replaced to resolve the reported issue.The device passed required performance verification tests per philips standards 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19154293
• MDR Text Key: 340924625
• Report Number: 2518422-2024-21328
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/09/2024
• Date Device Manufactured: 01/02/2013
• 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