MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS20401
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the m540 has lost its configuration and has very poor detection of the ecg signal asystole alarm, although a weak curve is present.
Additional Manufacturer Narrative
The investigation was started.Results will be provided in a follow up-report.
Event or Problem Description
It was reported that the m540 has lost its configuration and has very poor detection of the ecg signal asystole alarm, although a weak curve is present.
Additional Manufacturer Narrative
It was reported by the customer that the m540 has lost its configuration and had very poor detection of the ecg signal asystole alarm, although a weak curve was present.The customer reportedly changed the electrodes, leads, and the mode to attempt to remedy the issue with no remedy.The only solution was to switch to 4 leads to obtain a 12 lead ecg, and when the leads were removed the asystole would sound again.The m540 was removed from use.The fse noticed that the malfunctioning m540 had lost its configuration.The repair service tech confirmed that the device was repaired on jan 10, 2024, for mechanical defects including nibp connection and the endcap.The ipml was carried out, and additional testing of the ecg was carried out for 2 days without any ecg interruption.The logs were unavailable for analysis, and therefore the root cause cannot be determined.If the logs are provided for the date and time of the event, the complaint will be reopened to add log findings.Though the root cause cannot be determined, if the ecg reading is poor and has artifacts, there will be no asystole alarm.The device will provide a low-level advisory alarm for the artifact.Additionally, if the m540 loses configuration, alarm limits and settings may be lost.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA ; 2156602400
• MDR Report Key: 18503360
• Report Number: 1220063-2024-00004
• Device Sequence Number: 18164770
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)190729(93)MS25510-60
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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 Catalogue Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown