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

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 10aug2020.

Event Description

The customer reported a ventilator with high battery temperature.This event was reported to have occurred during clinical use.There was no allegation of harm associated with this report.

Manufacturer Narrative

G4: 02oct2020.B4: (b)(6) 2020.The manufacturer's field service engineer (fse) performed remote troubleshooting.It was reported that the battery was also low.The customer was advised to charge the battery.The customer indicated they would order a spare battery.Additional information has been requested to confirm if the battery has been replaced, and if the customer is still experiencing any issues.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.

Manufacturer Narrative

G4: 04oct2020.B4: 17nov2020.The field service engineer confirmed that the battery was almost empty and advised the customer to charge it and to order a spare battery.Per the operator's manual, a high battery temperature alarm can occur if the battery is almost depleted.The customer ordered a new battery as per advice, and did not call back to report further issues with the unit or to provide information on how the issue was resolved.The age of the battery and patient information was not provided.The system fully met specifications and was returned to use.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: 10388951
• MDR Text Key: 203329808
• Report Number: 2031642-2020-02745
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 07/21/2020
• Supplement Dates FDA Received: 10/05/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER