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

Model Number C20

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that it was not possible to generate vacuum with the auxiliary o2 and suction unit.The control knob for regulation of vacuum had become inoperable.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Event Description

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

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The replaced o2 auxiliary and suction unit was returned for investigation.The investigation revealed that the cause of the reported issues with creating vacuum was damages and cracks on the bacterial filter o-ring/seal which resulted in a leakage and thus prevented the suction unit from creating vacuum as intended.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7918848
• MDR Text Key: 122457888
• Report Number: 8010042-2018-00510
• 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
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• 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
• Device Age: YR
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1