MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BI-PAP FOCUS

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting component 76 capacitor failure on the bipap focus ventilator.The device was not in clinical use.There was no harm to a patient or user reported.Philips service provided a service proposal to the customer for corrective action.Further service is pending customer approval.

Manufacturer Narrative

Per a philips healthcare service bulletin, the end of support date for the bipap focus ventilator was (b)(6) 2019.Accessories, supplies, upgrades, and repair support parts associated with the bipap focus ventilator were made available through the end of support date.The bulletin with an issue date of (b)(6) 2014, informed the customer of the discontinuance of the bipap focus ventilator and that support would end after five years due to it being an aging product whose technology and design has been superseded.There was no work performed by philips service.The investigation concludes that no further action is required at this time.If additional information is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, NON-LIFE-SUPPORTING
• 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: 18453577
• MDR Text Key: 332192087
• Report Number: 2518422-2024-00890
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• 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: BI-PAP FOCUS
• Device Catalogue Number: 1028785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/23/2024
• 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