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

Catalog Number	MS13466
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the user witnessed a patient with a high heart rate, but the patient monitor did not appear to be visually showing the patients symptoms.There was no report of an adverse event or patient injury.
Event or Problem Description
It was reported that the user witnessed a patient with a high heart rate, but the patient monitor did not appear to be visually showing the patients symptoms.There was no report of an adverse event or patient injury.
Additional Manufacturer Narrative
It was reported to draeger that the delta xl would not visually display the patient's symptoms.Information and logs needed to investigate this reported behavior were requested.A draeger systems engineer visited the customer's site and found the reported issue to be a clinical configuration problem, so the requested materials were not provided.It was reported that there were no malfunctions found with any of the draeger products in use.There were no configuration actions taken at the customer's site per their request.No draeger device malfunction found.

• Brand Name: INFINITY 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 ; 2156602400
• MDR Report Key: 18720781
• Report Number: 1220063-2024-00021
• Device Sequence Number: 5586858
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: 04049098004169
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: MS13466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2005
• 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