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 Cardiac Arrest (1762)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The investigation into this complaint consisting of an evaluation of the ventilator¿s logs and examination of the ventilator has been completed.The field service engineer found no fault with the ventilator and no parts were replaced.The logs show that the ventilator while in standby, it was unplugged from the mains and it switched over to battery operation.While still on battery operation 15 minutes afterwards, ventilation was started and soon after the ¿battery operation audio alarm¿ was turned off.This implies that while the low priority alarm was visible on the screen but there was no audible sound.This ventilation period continued for 32 minutes until the ventilator was set to the standby mode but still running on batteries.Ventilation was restarted again after two minutes but still on battery power and run for 68 minutes.This ventilation period ended with the reported event of the shutting down of the ventilator due to battery power depletion.The shutdown was preceded first by the alarm ¿low battery voltage¿ 9 minutes before the shutdown.The second alarm ¿no battery capacity¿ was activated 4 minutes afterwards.The shutdown occurred 5 minutes later and was logged with ¿system shutdown power low¿ indicating that there was no battery power left to run the ventilator.The alarms ¿low battery voltage¿ and ¿no battery capacity¿ are high priority alarms and cannot be silenced which implies that the ventilator alarmed continuously for 9 minutes before shutting down.The ventilator was turned on again 14 minutes after the shutdown while plugged into mains and ventilation was restarted one minute afterwards.The logs show that at the ventilator shut down after depletion of battery power.The ventilator had run on battery operation during two ventilation periods and standby time totaling 117 minutes on two batteries.The ventilator activated appropriate alarms that were both visible and audible for nine minutes before it shut down.The ventilator was turned on while on mains 14 minutes after the shutdown and ventilation was restarted.The conclusion the matter is that there was no ventilator malfunction.The cause of the shutdown was depletion of battery power.

Event Description

It was reported that the ventilator shutdown while it was connected to a patient.The patient suffered a cardiorespiratory arrest.The patient survived the cardiorespiratory arrest and is still on ventilator therapy.Manufacturer's ref.#: (b)(4).

• 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: 11588095
• MDR Text Key: 242903041
• Report Number: 3013876692-2021-00023
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2021
• Distributor Facility Aware Date: 03/02/2021
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2021
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 38 WK