MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS-MACHINE, ANESTHESIA

Model Number FLOW-I C20

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation generated technical error codes indicating ventilation control error, safety valve open and apl pressure exceeded.There was no patient harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

Our field service engineer has investigated the reported anesthesia workstation on site.The pressure transducer printed circuit board (pcb) was replaced to resolve the issue and sent back for further investigation.The provided logs confirm the reported issues.The returned pressure transducer pcb has been tested in an anesthesia workstation.It passed the first system checkout.A case was started, after around 3 hours it started alarming for fio2 low and 2 technical errors that indicate fresh gas airway pressure sensor error.A system checkout failed directly after that.The zero pressure voltage has been measured on the returned pcb after that, it showed a major drift 11,23v.It was noticed as well with ocular inspection that there was a contamination around the sensor.No further inspection is needed as ingress of liquid substances can lead to a short circuit/malfunction of the affected part.The pressure sensor is confirmed that it is drifting with time, which caused the reported issue.A previous investigation on similar problem concluded that the liquid contamination had the same substances that is used in cleaning agents.Excessive use of cleaning detergents may lead to the reported issue.A defective pressure transducer may lead to inaccuracy in pressure measurement.Appearance of this failure will be noticed by the user by generated high priority alarms.If present, the fault will be detected during the system check out.

Event Description

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

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• 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: 15320138
• MDR Text Key: 303417489
• Report Number: 8010042-2022-01503
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1