MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 348 EX; RL 348 EX

Catalog Number 10844678

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens service went on site and performed a complete system check.Several calibrations and control measurements were performed successfully.The technician carried out a device briefing and discussed proper handling of the instrument.The customer stated that the sensor is not available to be returned for investigation.Also stated was the fact that the customer was aware of the qc failure.The customer stated that there was no comparative measurement made for patient #2 and the results for both patients were believed to be incorrect.The results were reported to the physician and the physician questioned the results and the results were not used.

Event Description

The customer reported low po2 results run on the rl348 ex when compared to the expected values for two patients.There was no report of injury due to this event.

• Brand Name: RAPIDLAB 348 EX
• Type of Device: RL 348 EX
• 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: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 8622285388
• MDR Report Key: 8460230
• MDR Text Key: 140176919
• Report Number: 3002637618-2019-00035
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/28/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 10844678
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/28/2019
• 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