MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR SERVO-I VENTILATOR; VENTILATOR, CONTINUOUS (RESPIRATOR)

Device Problem Protective Measures Problem (3015)

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

Event Date 08/08/2020

Event Type  malfunction  

Event Description

A read audible alarm (technical error 27) appeared on the servo-i ventilator system.

Event Description

A read audible alarm (technical error 27) appeared on the servo-i ventilator system.

• Brand Name: SERVO-I VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): MAQUET CARDIOVASCULAR; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 10476693
• MDR Text Key: 205122972
• Report Number: 10476693
• 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
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Event Location: Other
• Date Report to Manufacturer: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24455 DA