MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC DELTA XL; PHYSIOLOGIC MONITORING SYSTEM

Model Number	N/A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the delta xl went black but that beeping could still be heard.She said after their check in the morning they hooked up all the leads and put it in standby.No adverse patient impact or death reported.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the delta xl screen went black while in use.The anesthesia manager reported that after their check of the monitor, they hooked up all the leads and put the device into standby.When the monitor was attached to the patient the delta xl screen went black so the device was replaced to continue with the procedure.There were no adverse conditions reported for the patient under care.Several requests were made to gain additional patient information but it was not provided.The draeger repair technicians evaluated the faulty delta xl monitor and identified the root cause of the reported problem to be a faulty main processor printed circuit board (pcb).The board was replaced to restore the monitor's functionality.In addition, the monitor sustained heavy damage during shipment to the repair center.The delta xl monitor was repaired by replacing the rear housing, the front bezel assembly and the language label along with the right panel and label which were all found to be damaged.The nbp filters were replaced per preventative maintenance.The monitor was tested by service and it passed all functionality testing performed.
Event or Problem Description
The customer reported that the delta xl went black but that beeping could still be heard.She said after their check in the morning they hooked up all the leads and put it in standby.No adverse patient impact or death reported.

• Brand Name: DELTA XL
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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 ; 9784828529
• MDR Report Key: 20098712
• Report Number: 1220063-2024-00103
• Device Sequence Number: 20917964
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: (01)04049098004169(11)130916(93)MS18596-40
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: N/A
• Device Catalogue Number: MS18596
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown