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

Model Number 10492730

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

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 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.

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
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9844902
• MDR Text Key: 183973660
• Report Number: 3002637618-2020-00012
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (y/n): N
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10492730
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1