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

Catalog Number	MS18596
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the delta xl display lagged when the rotary knob was used, and that the patient vital display was interrupted and reset.Once the endoscopy case was finished, the delta xl restarted without alarms. the anesthesia machine in use was not impacted, and there was no reported injury or patient death.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the delta xl's rotary knob lagged in response, the patient's vital signs were interrupted and there was a shutdown of the monitor.Draeger reviewed the delta xl logs provided and there were no entries found for the reported date of event ((b)(6) 2024).No other logs or information was made available.The mrc repair center in telford found the cause of the delta xl intermittently shutting down was due to a faulty main processor pcb.The board was replaced with an upgraded a107 pcb.Damage to the monitor was addressed by replacing the rear housing, front bezel assembly and the language label.The internal battery and the nibp filters were replaced as a preventative maintenance measure.The rotary knob was not found to be malfunctioning during testing but it was replaced as part of the front bezel assembly.The monitor passed all testing after repair was performed and was cleaned for return to the customer.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that the delta xl display lagged when the rotary knob was used, and that the patient vital display was interrupted and reset.Once the endoscopy case was finished, the delta xl restarted without alarms. the anesthesia machine in use was not impacted, and there was no reported injury or patient death.

• 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 19051509
• Report Number: 1220063-2024-00039
• Device Sequence Number: 7355234
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: (01)04049098004169(11)110629(93)MS18596-34
• 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: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: MS18596
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2011
• 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.; N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown