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

Model Number V60 V60PLUS VENTILATOR

Device Problem Defective Alarm (1014)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the alarm, "primary alarm failed." had occurred.It was reported there was no patient involvement at the time the issue was discovered.The customer and remote service engineer (rse) reviewed the suggested repair for the alarm per the service manual and it was discovered that the primary speaker (motor controller (mc) speaker) had a reading of 9.7 volts, which is out of the tolerance range of 6.8 - 9.2 volts.The rse then discussed the replacement procedure with the customer and advised the replacement of the speaker assembly.The rse provided the customer with the part number of the speaker assembly.Investigation is ongoing.

Manufacturer Narrative

H10: the customer replaced the speaker assembly 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18750722
• MDR Text Key: 335895852
• Report Number: 2518422-2024-08896
• 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 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: 02/15/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Date Device Manufactured: 06/24/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1