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

Catalog Number 6487800

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

It was reported that the therapist noticed that the oxygen concentration displayed by the ventilator was fluctuating while it was connected to a patient.There was no patient harm.(b)(4).

Manufacturer Narrative

The reported problem was investigated on-site by our field service engineer (fse).The fse performed a visual inspection without any deviations noted.A simulated use testing on a test lung for two hours was also performed, the test showed only minor fluctuation of the oxygen concentration.There were no o2-alarms generated.As a precaution the fse replaced the control printed circuit board.The ventilator than ran for 2 more days without any further issues noted.Our investigation consists of a device log evaluation, as no part has been returned.The evaluation of the device logs shows that there was no technical alarms during the given date of event, or before, that could indicate a technical failure on the ventilator unit.The logs could confirm the reported alarm regarding high o2 concentration, the logs also show that the alarm ¿air supply pressure: low¿ was generated prior to this alarm conditions.The ventilator is designed to switch to 100% oxygen if the air supply pressure should fail, below 2.5 bars.Our conclusion of this complaint is that most probable cause to the alarms was an insufficient air supply pressure from the wall gas system at the hospital, and that triggered the alarm for ¿high oxygen concentration¿.

Event Description

(b)(4).

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6702417
• MDR Text Key: 79906115
• Report Number: 8010042-2017-00318
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/15/2017
• Date Device Manufactured: 11/09/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1