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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens has issued an ufsn 33114 on july 2015 to notify affected customers regarding dual port issue and asked them to stop using the dual port feature.As per ufsn, section 'actions to be taken by the customer'; "determine if your system is configured to use dual port lis transmission.If the system is currently set up with dual lis transmission enabled, one of the ports (either serial or ethernet) needs to be disabled." customer was informed of the ufsn by a siemens customer service engineer (cse), however, the customer continued to use the dual port future by their responsibility.The event has occurred due to an operator error.

Event Description

Customer reported that result was not sent around 23:45pm on (b)(6) 2015.There was no report of serious injury due to this event.

• 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: 5191229
• MDR Text Key: 30393905
• Report Number: 1217157-2015-00152
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-2479-2015
• Patient Sequence Number: 1