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

Model Number BI-PAP FOCUS

Device Problem Failure to Sense (1559)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device prompts an alarm indicating that the pipeline is disconnected.It was reported there was no patient involvement at the time the issue was discovered.

Manufacturer Narrative

E1 reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Manufacturer Narrative

A philips service engineer was not able to evaluate nor repair the device; therefore, it could not be determined if it failed to meet specifications.The customer didn¿t accept the quote and no work order was generated.It is unknown what the outcome of the service event was, and no further information could be obtained.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philip's normal complaint procedure.

• 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: 18488836
• MDR Text Key: 332901225
• Report Number: 2518422-2024-01823
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BI-PAP FOCUS
• Device Catalogue Number: 1028785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• 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