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

Model Number	10492730
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue has been escalated to software engineering for evaluation.The trace log provided by the customer had the incorrect time frame.Siemens has requested the trace log with the correct time frame.The cause of this event is unknown.
Event or Problem Description
The customer reported they ran a patient on the rp 500 and the user confirms the patient id was scanned correctly, all results on the patient's chart are correct, the printouts from the analyzer are correct and the rapidcomm results are correct.When the user recalled the patient list, several results from the previous 24 hours were all overwritten with one, different patient id.There was no report of injury due to the event.
Additional Manufacturer Narrative
Siemens has made multiple "attempts" to acquire additional information.There has been no response from the customer.Since the hard drive is not available, no conclusion can be made.The customer stated that all rapidcomm results are correct, all printouts are correct and all patient results on the chart are correct.The logs provided do not include information required to determine the root cause.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9844902
• Report Number: 3002637618-2020-00012
• Device Sequence Number: 765183
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1