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

Model Number 6487800

Device Problem No Display/Image (1183)

Patient Problem Salivary Hypersecretion (4486)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Patient volumes were not showing up on maquet critical care ab servo-i base unit neonatal/adult intensive-care ventilator.No leak was found on the circuit and wires of the servo-i base unit neonatal/adult intensive-care ventilator.Patient was suctioned with large amount of secretions/mucus plugs noted during the process.Subsequently, the patient was placed back on ventilator and still reading the same values.Patient taken off ventilator and used artificial manual breathing unit (ambu) bag to ventilate patient while new ventilator was put in place.Patient placed on new ventilator with no issues noted.

• Brand Name: SERVO-I BASE UNIT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11384587
• MDR Text Key: 233748805
• Report Number: 11384587
• Device Sequence Number: 1
• Product Code: CBK
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6487800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Date Report to Manufacturer: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA