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

Device Problem Alarm Not Visible (1022)

Patient Problem Hypoventilation (1916)

Event Date 08/09/2020

Event Type  malfunction  

Event Description

Ventilator gave no indication of failure, however results from blood gases indicated the pt was not ventilating properly.Although the pt was on max settings (12 ml/kg, rate 44, peep 10) the pips remained low (23) and consistent with changes.The ventilator was switched with another servio and patient's ventilation improved as well as an increase in pips with lower settings.

• Brand Name: SERVO I VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10487526
• MDR Text Key: 205489223
• Report Number: 10487526
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2020
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 DA