MAUDE Adverse Event Report: RESPIRONICS, INC. AF541; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 1121065

Device Problem Pressure Problem (3012)

Patient Problem Injury (2348)

Event Date 07/24/2020

Event Type  Injury  

Event Description

Pressure injury noted on right eye from medical device.

• Brand Name: AF541
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1740 golden mile highway; monroeville PA 15146
• MDR Report Key: 10453375
• MDR Text Key: 204347309
• Report Number: 10453375
• Device Sequence Number: 1
• Product Code: BZD
• 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

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1121065
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22265 DA