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

Model Number SERVO-I

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the ventilator shutdown during patient treatment.There was no patient harm.Manufacturer ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

Investigation of the reported complaint is complete.Evaluation of the received device logs show that the ventilator device was shut down on (b)(6) 2021 while in battery operation.When the ventilator device is not mains connected, the installed batteries are not charged.On (b)(6) 2021, the device was started and a pre-use check performed.Then on (b)(6) 2021, the ventilator device was set to battery operation, and taken off battery operation, several times.Ventilation was initiated four times during this day.The total running time while in battery operation before the reported shutdown was approximately 165 minutes, which equals to 2.75 hours.The last battery operation alarm before the shutdown was at 11:05 am.At 11:45 am the low battery voltage alarm was generated.At 11:49 am, the alarm ¿no battery capacity¿ was generated and 30 seconds later, the device shut down due to low power.The logs do not reveal any information regarding the total battery capacity when the second ventilation session was started, which led to the shutdown.The technical log does not contain any technical alarms that could indicate on a permanent device malfunction.¿use testing¿ of the four battery modules did not reveal any faults.The shown battery capacity when fully charged is 46 min per battery module.When a ventilation session is initiated the device runs for about 4 hours and 20 min before running out of power completely.Based on the performed investigation, the returned battery modules are working according to specifications with no errors.There was no device malfunction.The issue is considered a usability issue.

• 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: 11724363
• MDR Text Key: 247273805
• Report Number: 8010042-2021-00924
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1