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

Model Number C20

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation failed the leakage test during system check out.There was no patient connected to the device during the event.(b)(4).

Manufacturer Narrative

The company service engineer investigated the anesthesia workstation at the hospital and concluded that the manual/automatic ventilation valve membrane in the patient cassette and the actuator manual/automatic ventilation valve had been damaged.The damaged parts were replaced but were not returned for investigation.Images of the damaged parts were received and our conclusion is that the damages were caused by attempting to remove the patient cassette while the manual/automatic ventilation valve actuator was in its upper position, i.E excessive or inadequate physical force had been applied to the patient cassette.The system check out in the supplied log failed due to the leakage caused by the damaged parts.Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003.(b)(4).

Event Description

(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: 7454491
• MDR Text Key: 106722166
• Report Number: 8010042-2018-00200
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 05/17/2018
• Date Device Manufactured: 06/18/2014
• 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