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 Consequences Or Impact To Patient (2199)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

It was reported that several alarms for leakage were generated during treatment.The logs show alarms for high airway pressure.There was no patient harm.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

The investigation into this complaint has been completed.The anesthesia system was investigated on-site by our field service engineer and the patient cassette was replaced.The reported issue has not re-occurred after this.The patient cassette was returned for investigation and device logs were received.The returned patient cassette was tested in a reference system.The system checkout passed without deviations and simulated use testing was performed during several days.The reported failure was not reproduced during investigation of the patient cassette.Evaluation of the received device logs shows that system checkout performed prior to and after the reported event were successful.The reported alarms were confirmed.There are no recordings in the technical log indicating any technical malfunction in the system.The conclusion, based on that the reported issue has not reoccurred after replacement of the patient cassette, is that the reported leakage alarms most probably were caused by an expiratory flow measuring error.The cause of the airway pressure high alarms has not been determined.

• 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: 11372413
• MDR Text Key: 233285452
• Report Number: 8010042-2021-00480
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1