MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number	6677300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the anesthesia system was in use several alarms for leakage were generated.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Our field service engineer investigated the anesthesia machine on site.The machine was tested with successfully results.The reported issue could not be reproduced.No parts were mentioned as replaced and no further issues has been reported after this reported event.A complete set of device logs was saved and sent for evaluation.The logs show a successful system checkout prior to and during the event and there is no indication of a technical malfunction in the system at the time of the event.However, the internal log confirms the reported leakage alarms.In addition to the leakage alarms, other clinical alarms such as respiratory rate: high, fio2: low, peep: low, expiratory minute volume: low, etco2: low, respiratory rate: low and fico2: high were active.The leakage may have been due to the breathing circuit which was not changed until after the case.However, the root cause of the reported issue has not been established by this investigation.
Event or Problem Description
Manufacturer's ref: #(b)(4).
Additional Manufacturer Narrative
A correction of field # d1 brand name, # d4 version or model #, # d4 unique identifier (udi) # and h4 manufacturer date were required.D1 ¿ brand name - previous brand name: flow-i, corrected brand name: flow-i c30 d4 ¿ version or model # - previous version or model #: flow-i c30, corrected version or model #: 6677300 d4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #: (b)(4) h4 ¿ manufacture date - previous manufacturing date: 06/28/2016, corrected manufacturing date: 06/16/2016.
Event or Problem Description
Manufacturer's ref: (b)(4).

• Brand Name: FLOW-I C30
• 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: 18054218
• Report Number: 8010042-2023-02115
• Device Sequence Number: 20552310
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)160616
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 6677300
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 06/14/2024; 06/06/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 06/14/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose