MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Catalog Number	11416751
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No investigation could be conducted.The customer was unable to provide relevant details and data files for investigation.The customer believes this may have been attributed to user error; however, no supporting information has been provided.The definitive root cause cannot be determined.The customer is currently operational.
Event or Problem Description
Customer reported that their instrument reverted back to the previous patient's information/demographics when user/operator scanned patient barcode and ran the patient sample.There is no report of injury due to this event.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 24930571
• Report Number: 3002637618-2026-00039
• Device Sequence Number: 17482168
• Product Code: CHL
• UDI-Device Identifier: 00630414286143
• UDI-Public: (01)00630414286143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192240
• 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
• Report Date (Section B): 04/20/2026

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: 11416751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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