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 Type  malfunction  

Event Description

It was reported that the on/off switch on the suction unit broke.There was no patient involvement.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The anesthesia system was investigated at the facility by our company field service engineer.It was concluded that the built-in suction device could not be turned on.The built-in suction device was replaced and the anesthesia system was cleared for clinical use after successful testing.The replaced suction device was returned for investigation.The investigation concluded that a screw (including a bushing), which is a part of the actuator located behind the on/off switch had broken off and thus prevented the suction device from turning on.The broken part was not included in the box when the suction device was received and cannot be investigated further, based on a received picture, it is suspected that the screw had unexpectedly worked its way out of the threads and thus being exposed to a force exceeding the amount of force the part was able to withstand when turning on the suction device.The broken part has a specified tightening torque of 0.95nm.We have not been able to determine if the specified tightening torque of 0.95nm actually was used.

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: 17456781
• MDR Text Key: 320380877
• Report Number: 8010042-2023-01496
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: FLOW-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1