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

Catalog Number	MS18597
Medical Device Problem Code	Inaudible or Unclear Audible Prompt/Feedback (2283)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was no alarm heard for an asystole on a delta device.No additional information regarding the event was provided.There was no report of patient injury or death.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
It was reported to draeger that the asystole alarms were not heard on the delta monitor.The draeger engineer that serviced the delta monitor at the customer's site confirmed the cause of the reported behavior was the result of the or locked option being enabled by the user, which causes the alarms to be silenced.Testing of the delta monitor did not indicate any malfunctions as the device was found to be operating as intended.The cited delta monitor has been returned to use for patient monitoring.Root cause was identified as user error.No further issues have been reported.
Event or Problem Description
The customer reported that there was no alarm heard for an asystole on a delta device.No additional information regarding the event was provided.There was no report of patient injury or death.

• Brand Name: DELTA
• 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: 19144921
• Report Number: 1220063-2024-00046
• Device Sequence Number: 12752604
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)220104(93)MS18597-73
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: MS18597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown