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

Model Number	10492730
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested the trace logs and sensor data for investigation.The customer stated that repeat testing was performed to confirm correct results that met the clinical picture and a corrected report was issued.The customer stated the instrument is currently operational.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant thb results from their rp500 instrument compared to retesting of the same samples on a non siemens instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has shown due diligence in attempting to obtain more information form the customer, and the customer has not responded.Since patient logs are not available no further investigation is able to be preformed.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10454504
• Report Number: 3002637618-2020-00044
• Device Sequence Number: 14344876
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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 Model Number: 10492730
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1