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

Model Number	6888520
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preventive maintenance on the anesthesia system it was detected that the ground pin in the mains power inlet was a bit loose and was thus giving a bad protectively earth.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.The pm was completed, and during the electrical safety tests performed by our field service engineer (fse) , the protective earth resistance at the mains power inlet measured 1 ohm, which is outside the specified limit.According to the requirements for anesthesia systems, the protective earth resistance at the mains power inlet should not exceed 100 mohms (0.1 ohm).Our field fse tightened the socket connectors, after which the protective earth reading was within the acceptable range.Our conclusion, based on the available information, is that tightening the socket connectors resolved the reported issue.However, the underlying cause of the loose ground pin could not be determined.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I C20 ANESTHESIA SYSTEM
• Common Device Name: 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: 22476802
• Report Number: 8010042-2025-0001077
• Device Sequence Number: 15589464
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)210407
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: 6888520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown