MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB MAQUET SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problems Defective Alarm (1014); Failure to Read Input Signal (1581)

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

Event Date 10/05/2019

Event Type  malfunction  

Event Description

Blank to wave forms and settings.Touch screen was unresponsive to touch and alarms would not silence.Ventilator was removed from pt use and removed from service.Soma technology, (b)(6).Fda safety report id# (b)(4).

• Brand Name: MAQUET SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB
• MDR Report Key: 9172793
• MDR Text Key: 161851555
• Report Number: MW5090305
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR