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

Catalog Number	MS26372
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the m540 has shut down during operation and gave an alarm and could not be restarted.There was no report of patient injury or death.
Additional Manufacturer Narrative
It was reported to draeger that the m540 shut down while in use and gave a continuous alarm until the device battery eventually depleted.No adverse patient impact was reported.The device was evaluated by draeger personnel, who confirmed the malfunction, and found that various parts were damaged including the device housing, a mainboard defect, and a broken top cover.Multiple attempts were made for further information and to date no further information has been provided.The draeger technician repaired the device, including repairing the faulty mainboard.A mainboard failure could cause the device to alarm and shutdown however, an exact root cause of the mainboard failure cannot be determined due to insufficient information.After the repair, the technician conducted a function and software test, calibrated and did a final check of the device in accordance with manufacturers specifications.No further issues have been reported.Furthermore, according to the pictures sent in, damage to the housing of the unit could be consistent with drop damage and according to the ifu, a visual inspection should be conducted before every use, and the user should ensure that there is no damaged housing or other physical damage to the device.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 20212894
• Report Number: 1220063-2024-00107
• Device Sequence Number: 7328434
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)150420(93)MS26372-27
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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
• Device Catalogue Number: MS26372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown