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

Model Number SERVO-I

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that water entered into the machine.There was no patient harm.Manufacturer ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

It was reported that water overflowed into the ventilator.There was no patient harm.The service engineer cleaned all printed circuit boards and saved device log files.The ventilator was returned for clinical use after passed functional tests.No part was reported replaced.No further issues have been reported.No picture showing evidence of liquid spill or corrosion was received.No date of event was determined, the aware date was mars 18, 2021.The evaluation of received device logs shows clinical alarms on march 10 and earlier, but no technical errors.Liquid in the ventilator may create an acute short circuit and stop of ventilation.Liquid/moisture on pc boards may also lead to corrosion which may lead to a failure/short circuit and stop of ventilation.Alarms will be generated.The conclusion is that water/liquid in the ventilator was confirmed by the service engineer.It was not explained how the water entered the ventilator.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11581135
• MDR Text Key: 242692083
• Report Number: 8010042-2021-00676
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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
• Date Manufacturer Received: 10/27/2021
• Patient Sequence Number: 1