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

Catalog Number 6487800

Device Problem Device Inoperable (1663)

Patient Problems Cardiac Arrest (1762); Death (1802); Encephalopathy (1833)

Event Date 04/01/2016

Event Type  Injury  

Event Description

The hospital biomed made a call requesting a download of logs from the ventilator to ascertain the time when ventilation was restarted after disconnecting the ventilator.It was stated that while the ventilator was connected to a patient, ventilation was stopped to enable the change of a swivel connector at around 9.30 a.M.The central monitoring system gave an asystole alarm.At this time it was observed that the patient was not being ventilated, had suffered a cardiac arrest and, the ventilator was found to be in the standby mode.A cardiopulmonary resuscitation of the patient was done and the ventilator was connected back to the patient.Ventilation with the same ventilator continued without problems to approximately 2.50 p.M., when it was decided to disconnect it from the patient to enable its investigation.Ventilation of the patient continued with another ventilator for 4 days.The hospital alleges that the general patient condition of the patient deteriorated after the cardiac arrest with postanoxie encefalopathie during the standby period which the hospital estimates to have lasted about 6-7 minutes.The patient died 4 days later.(b)(4).

Manufacturer Narrative

The ventilator was not sequestered after the event but ventilation was resumed and the ventilator functioned without problems.On removal later on from service, the logs were downloaded and no parts were replaced.The investigation therefore consists of an evaluation of the logs and information that was received from the hospital.The event time in the event log that contains information that would show the time the ventilator was set to the standby mode and how long this period lasted, was overwritten and missing due to continued use.The event log has a limited storage capacity.Old log entries are overwritten as new ones are entered.The technical log has no entry on the day the event thus indicating nothing to suggest a technical problem at the time.There was no ventilator malfunction at the time.Ongoing ventilation was stopped by the user and the ventilator was actively set into the standby mode and ventilation was not restarted.The ventilator¿s stay in the standby mode according to the hospital was about 6-7 minutes but has not been confirmed by because the logs were overwritten.When the ventilator is in the standby mode, it does not ventilate, the word ¿standby¿ in red large letters is displayed on the screen and a ¿patient not ventilated¿ message flashes.The cause of the event is attributed to use error.Leaving the ventilator in the standby mode while it is connected to patient who is in need of ventilator therapy means that the patient is not ventilated which could lead to desaturation.

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: 5578242
• MDR Text Key: 42744750
• Report Number: 8010042-2016-00211
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/06/2016
• Date Device Manufactured: 11/24/2008
• 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; Life Threatening; Required Intervention
• Patient Age: 65 YR