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

Catalog Number	MS18596
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported there was no spo2 value on displayed on the monitor, showing ¿***¿ to alert the user of the condition.Several requests were sent out by the investigator without a response being sent to provide the necessary information to perform a proper evaluation into the reported issue.With the information needed, a precise root cause could not be determined nor can the malfunction be verified.In addition, there was no draeger service involved as the customer is out of the draeger service contract.Maintenance and repairs on the device are generally handled by a 3rd service provider, or by a hospital technician.Service was offered but the hospital rejected draeger service however, did confirm the issue was due to faulty ibp cuff and there was no malfunction of the monitor itself.H3 other text : device was not returned for evaluation.
Event or Problem Description
The customer reported that, while preparing for surgery, the sp02 value could not be viewed on the monitor, and that users swapped out the device.The patient had been hospitalized for acute appendicitis on (b)(6) 2023, due to undergo a laparoscopic appendectomy the same day.The patient was being administered a sodium chloride injection as part of the procedure.Ecg monitoring was reported to function, but no blood oxygen saturation was displayed, and the users swapped out the monitoring device, reporting a prolonging of administration of anesthesia.No patient injury or death was reported.

• Brand Name: DELTA XL
• 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 ; 9784828529
• MDR Report Key: 19404063
• Report Number: 1220063-2024-00061
• Device Sequence Number: 6955934
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: (01)04049098004169(93)MS18596
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS18596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Sex: Unknown