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

Catalog Number 10492730

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens is in process of investigating the issue.The cause for the falsely low pco2 result is unknown.

Event Description

Customer reported falsely low pco2 result on the analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens customer care center (ccc-ts) was unable to obtain log files from the customer to investigate the issue.The log files would allow siemens to review sensor response, calibration, qc and any error messages or flags on the system.The customer has not reported any further discrepancies.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5112082
• MDR Text Key: 27147939
• Report Number: 1217157-2015-00140
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10492730
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1