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

Catalog Number	MS18597
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the delta monitor did not alarm when the patient became desaturated.Draeger service engineering reviewed the images of the delta logs that were provided.These logs were determined to be inconclusive.The delta logs did not log any spo2 events based on the reported date and time of the event.The lower spo2 lower limit was set to 88 and the logs do show readings of spo2 <88% at various times well after the reported time of event.To further investigate into these times additional logs and information were requested but could not be provided.It was reported that the biomed saw an entry in the delta logs that someone had silenced an alarm but further information regarding this statement could not be provided.These inadequate logs do not make it possible for the investigation to continue and therefore a root cause for the reported event was unable to be determined.If the reported issue reoccurs in the future it is requested to provide the logs from all the involved devices along with as much information as possible.
Event or Problem Description
The customer reported that, during patient monitoring, the delta did not alarm during a patient's desaturation.The reported event occurred in an icu on (b)(6) at 1400.There is no information stating there is any adverse patient impact.
Event or Problem Description
The customer reported that, during patient monitoring, the delta did not alarm during a patient's desaturation.The reported event occurred in an icu on feb 12, at 1400.There is no information stating there is any adverse patient impact.
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.H3 other text : 101202.

• Brand Name: DELTA
• 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: 18921326
• Report Number: 1220063-2024-00030
• Device Sequence Number: 15332227
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)101202(93)MS18597-09
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2011
• 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