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

Model Number FLOW-I C20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that when the on/off knob on the auxiliary o2 and suction module was switched, the knob came loose.There was no patient harm.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

The customer contacted our field service engineer to get a new knob.Our field service engineer confirmed that the on/off knob on the o2 auxiliary and suction module was missing and provided a new knob.Our field service engineer did not see the defective knob and there is no information on the exact circumstance for how it broke/came loose.The auxiliary o2 and suction module consists of two parts; the flow meter unit with the intended use to provide oxygen for patient therapy and the suction unit with the intended use to extract body fluids from the stomach and airways.The suction pressure is regulated by means of the on/off switch and the suction unit regulatory valve.In this case it was the on/off switch on the suction unit that came loose.The reason why the knob came loose/broke has not been determined.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11035956
• MDR Text Key: 222640412
• Report Number: 8010042-2020-01256
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1