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

Catalog Number 6694800

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045); Multiple Organ Failure (3261)

Event Date 02/05/2018

Event Type  Death  

Manufacturer Narrative

The ventilator was investigated by our field service engineer (fse).No device errors could be detected and no parts were replaced.The ventilator passed all functional and safety tests and was cleared for clinical use.The ventilator logs did not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.Additional information from the user facility stated that they are using two different ventilator brands.Their operating procedures how to start ventilation are different.The cause of the reported incident is attributed to user error.There is no indication of a ventilator malfunction at the time of the event.(b)(4).

Event Description

It was reported that the patient was hospitalized for an acute respiratory distress syndrome complicated with a multi-organ failure.The patient was transferred to another site of the facility to perform a coronary angiography.When returning to icu, the patient was connected to the ventilator, but ventilation was not correctly started.The user did not press the start ventilation button since it was believed that ventilation would start directly by itself when connecting the patient.Clinical consequences was cardiac arrest, resuscitation with cardiac massage (30 min) & 20 mg adrenaline administration following bradycardia (hr 50 beats/min).The patient then had a second cardiac arrest which led to the death.(b)(4).

• Brand Name: SERVO-U
• 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: 7467964
• MDR Text Key: 106716998
• Report Number: 8010042-2018-00209
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/12/2018
• Date Device Manufactured: 08/25/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 103