MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2018

Event Type  malfunction  

Event Description

It was reported that during patient treatment, the medical staff had difficulties to ventilate the patient.There was no patient harm.(b)(4).

Manufacturer Narrative

The company field service engineer visited the hospital and investigated the anesthesia workstation.Although no issues were found, the patient cassette was preventively replaced and sent in for investigation together with the device logs.The returned patient cassette.The patient cassette functions as intended.According to the test log, a successful sco was performed just prior to the event.There is no recorded sco after the event.The internal log contains clinical alarms such as fio2: low, etco2: low, expiratory minute volume: low and the technical log contains technical alarms indicating issues with the pressure during the event.We have not been able to determine the root cause of the reported issues.(b)(4).Ref.Exemption #: e2018003.(b)(4).

Event Description

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

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 7311373
• MDR Text Key: 101614201
• Report Number: 8010042-2018-00110
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 05/02/2018
• Date Device Manufactured: 03/25/2014
• 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