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

Catalog Number 10697306

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2013

Event Type  malfunction  

Event Description

Customer reported that the instrument flagged a d3 (slope error) error code.The d3 error code was due to the measurement cartridge.Customer indicated that due to the described situation the cardiovascular surgery ward was closed and some planned surgeries were cancelled.

Manufacturer Narrative

Customers have been shipped replacement cartridges to address the issue.Urgent field safety notice #(b)(4) revision a was sent to customers outside the u.S.To inform them to the issue.Product was not distributed to u.S.Customers.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; northern rd; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3645212
• MDR Text Key: 4205282
• Report Number: 1217157-2013-00254
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/13/2013

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: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1