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

Catalog Number 10697306

Device Problem Failure to Calibrate (2440)

Patient Problem Respiratory Distress (2045)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the measurement cartridge was replaced which corrected the issue.Siemens service went onsite and the analyzer is operational.Siemens is in the process of evaluating this event.The cause of this event is unknown.

Event Description

The customer stated that the oxygen parameter would not calibrate and they were not able to use the rp 500.This caused a delay in patient results.The o2 parameter was needed because the patient had difficulties with breathing.They couldn't start giving o2 without the results.The customer stated that there was no direct harm to the patient due to this event.

Manufacturer Narrative

Siemens has reviewed the data provided by the customer.The data the customer provided indicated that the po2 sensor failed due to d3 and d4 errors.Root cause was unable to be determined as the cartridge was not returned.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 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: 6723429
• MDR Text Key: 80577351
• Report Number: 3002637618-2017-00120
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR