MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 13july2019.Manufacturer's field service engineer (fse) evaluated the unit and confirmed the reported issue.Fse replaced the power supply brick, tahoe 120w, 18v p/supply to resolve the reported issue.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.

Event Description

The customer contacted technical support (ts) stating that the unit needed the power supply replaced.There was no patient involvement reported.The event date was not specified, estimate used.

• Brand Name: BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8787488
• MDR Text Key: 150983557
• Report Number: 2031642-2019-04533
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/14/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2018
• Initial Date FDA Received: 07/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2011
• 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