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

Model Number FLOW-C

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that the on/ off switch for the auxiliary o2 and suction device on the anesthesia workstation has failed and broken.There was no patient involvement.Manufacturer´s ref.#: (b)(4).

Manufacturer Narrative

The broken on/off switch knob was replaced and the unit was returned to clinical use.Investigations that has been performed on broken suction unit on/off switch knobs, show a mechanical stress in the plastic part.To prevent this from occurring the suction unit on/off switch knob has been improved.The material in the suction unit on/off switch knob has been changed to metal.The improved suction unit on/off switch knob was introduced in production line of new units in april of 2022.The suction unit on/off switch knob on anesthesia systems in the field will be replaced according to the field action z-1278-2022, z-1279-202.

Event Description

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

• Brand Name: FLOW-C
• 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 13042863
• MDR Text Key: 282489242
• Report Number: 8010042-2021-03022
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1278-2022, Z-1279-202
• Patient Sequence Number: 1