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

Model Number BI-PAP FOCUS SYSTEM, CHINA

Device Problem Device Sensing Problem (2917)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Philips received a complaint on the bi-pap focus device indicating that the unit had an error:blower sensor failure.The device was outside of use at time of the reported event.There was no patient or user harmed.The investigation is ongoing.

Manufacturer Narrative

B5: a good faith effort (gfe) response was received from the authorized service provider (asp) stated that the information regarding clarification of the allegation and resolution of the blower sensor issue was asked but unknown.No further information was received from the customer and philips was unable to confirm the final disposition of the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

This report is being submitted as a correction in response to corrective actions taken by the legal manufacturer.The manufacturer site number was incorrectly selected resulting in incorrect report numbers.A new mdr with the correct manufacturer site selected has been submitted under manufacturer report # 2518422-2023-18272.

• 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: 16336018
• MDR Text Key: 309268836
• Report Number: 2031642-2023-00461
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00989805632691
• UDI-Public: 989805632691
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-PAP FOCUS SYSTEM, CHINA
• Device Catalogue Number: 1028785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• Date Device Manufactured: 12/16/2013
• 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