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

Device Problems Computer Software Problem (1112); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 05mar2019.A follow-up report will be submitted once the investigation is completed.

Event Description

The customer contacted philips technical support (ts) stating that the service software on the unit is corrupt.The customer reported there was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec'd by mfr: 11apr2019.The device was evaluated.Resolution information was confirmed for the reported issue.The manufacturer's field service engineer (fse) performed remote troubleshooting.The fse determined that the customer was using windows 7, and advised that they must use a computer with xp.After switching to an xp computer, the error continued.The fse advised the customer to try downloading the software to the computer with xp directly.The customer requested the software for the real-time clock calibration.The fse provided parts id for the service software necessary for real time clock calibration.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 8391417
• MDR Text Key: 137969836
• Report Number: 2031642-2019-01273
• Device Sequence Number: 0
• Product Code: MNS
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1