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

Catalog Number	10492730
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens requested the parts, which includes the hdd cable and the hard drive, to be returned for investigation.The customer requested the parts to be replaced along with a measurement cartridge and a wash/waste cartridge.The cause of this event is unknown.
Event or Problem Description
The customer reported that on the rp 500, the hard drive wiring harness melted, producing smoke.There was no visible flames or exposure.There was no report of harm to any operator or patients.
Additional Manufacturer Narrative
No additional investigation for this issue was required.Siemens states that the issue was previously evaluated.The connector was changed on forward production in 2014.The connector in this complaint pre-dates that change.This facility is covered for parts and the biomed department does the service.The parts to the hard drive wiring harness have been replaced.Per investigation performed for this issue, root cause could not be determined.There have been no failures on rp500s manufactured since the corrective actions were implemented.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8566946
• Report Number: 3002637618-2019-00054
• Device Sequence Number: 19397603
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 10492730
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1