MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Catalog Number REF1021165

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/06/2020

Event Type  Injury  

Event Description

Pressure-induced injury to the nose when using a bilevel positive airway pressure (bipap) mask.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 10559590
• MDR Text Key: 207741709
• Report Number: 10559590
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: REF1021165
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2020
• Date Report to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA