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

Catalog Number 10697306

Device Problem Computer Software Problem (1112)

Patient Problem Not Applicable (3189)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens software group is investigating this issue.The customer stated that no patients were affected by this issue.The cause of this event is unknown.

Event Description

The customer reported an issue with the help button on the rp 500.When the help button is chosen to find solutions for error messages, the touchscreen of the instrument freezes instantly.The instrument with serial number (b)(4) is located in the trauma room.The customer also stated that they have an additional 15 more rp 500 instruments with the same issue.There was no reported injury due to this event.

Manufacturer Narrative

Corrected information: the customer reported that they observed the help button issue on only one rp500 (serial number (b)(4)) not on 15 additional instruments as was originally reported.The customer provided data files and a video which were reviewed by siemens software r&d.The video did not show this issue.There were no abnormalities in the data files provided.Siemens software r&d group was not able to reproduce this issue in-house.Siemens service went on site and while they initially indicated that they were able to reproduce the customer's observation, siemens service can no longer reproduce the issue.The customer stated that they are operational.Root cause cannot be determined based upon the information that the customer provided.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7176588
• MDR Text Key: 96823747
• Report Number: 3002637618-2018-00002
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K113216
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1