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

Model Number V60

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

Patient Problem Injury (2348)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Deep tissue pressure injury (dtpi) on bridge of nose related to wearing 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: 10454267
• MDR Text Key: 204395181
• Report Number: 10454267
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 144164-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Event Location: Other
• Date Report to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA