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

Model Number SERVO-I

Device Problem No Flow (2991)

Patient Problem Death (1802)

Event Date 01/18/2021

Event Type  Death  

Event Description

It was reported that the ventilator was connected to a patient at the time when the therapist set the ventilator to the standby mode while doing a patient circuit change.After the change the ventilator was not restarted to resume ventilation.The patient died.(b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer.No anomalies were found.The ventilator passed all functional and safety tests and was cleared for clinical use.No parts were replaced.Provided ventilator logs were reviewed.The event log contains a standby on the reported event date and time, (b)(6) 2021 at 8:45 am.The standby is preceded by a logged ¿standby button activated¿, which implies pressing the standby key by the user, followed by a logged ¿standby dialog confirmed¿ which implies pressing the option ¿yes¿ in the pop-up window whereafter the ventilator is set to the standby mode.This is an indication that the setting of the ventilator to standby mode was intentional.When the ventilator is set to standby, the indication ¿standby, patient not ventilated¿ is clearly visible on the screen and no waveforms or measured values are presented.Ventilation can then be started by pressing the start/standby key or by pressing the start ventilation touchpad on the screen.Successful pre-use check was performed prior the patient was placed on the ventilator on (b)(6) 2021 at 5:10 pm.The technical log does not contain any technical error codes to indicate a ventilator malfunction.There are no allegations from the user facility that a ventilator malfunction caused or contributed to the death of the patient.This conclusion is also supported by the log review and our field service engineer¿s examination and testing of the ventilator, which found no fault with the ventilator.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11278657
• MDR Text Key: 230247230
• Report Number: 8010042-2021-00258
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 88 KG