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

Catalog Number	MK31501
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to dräger that the cockpit of the patient monitoring system sporadically loses the screen image.As per report, a surgery had to be aborted in consequence of that.No consequences to the patient's health have resulted from the event, finally.Remark: based on the initial report received on nov.15th, the case was assessed as being reportable because a serious injury cannot be excluded in case of recurrence.On nov.22nd dräger however received the additional information that the initial surgery was aborted due to the monitor's malfunction.Consequently, the case underwent a re-assessment and was considered to meet the definition of serious injury due to the prolonged surgery time/hospitalization.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
T was reported to dräger that the cockpit of the patient monitoring system sporadically loses the screen image.As per report, a surgery had to be aborted in consequence of that.No consequences to the patient's health have resulted from the event, finally.Remark: based on the initial report received on nov.15th, the case was assessed as being reportable because a serious injury cannot be excluded in case of recurrence.On nov.22nd dräger however received the additional information that the initial surgery was aborted due to the monitor's malfunction.Consequently, the case underwent a re-assessment and was considered to meet the definition of serious injury due to the prolonged surgery time/hospitalization.
Additional Manufacturer Narrative
The customer reported that a c500 cockpit loses the image randomly on the screen.The draeger technician evaluated the device and to resolve the issue replaced the inverter board and display.The device was tested and put back into service.The c500 is a secondary monitor used to display patient data.Primary monitoring is performed by the m540 and there was no interruption in patient monitoring.The patient data and alarms are displayed on the m540.Network connectivity is also not affected.A loss of display would be obvious to the user; the net effect is that visibility of patient data during the clinical situation of a surgery is impaired.The field failure rate of the replaced parts is inconspicuous.

• 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18244236
• Report Number: 1220063-2023-00046
• Device Sequence Number: 15251704
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)170303(93)MS25510-42
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MK31501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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: NA.; NA.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown