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

Catalog Number 10492730

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Customer should not have run patient samples when aqc was turned off.Siemens representative reviewed secured options and system access with customer.The cause of the event was determined to be an operator error.

Event Description

Customer run 2 patient samples when aqc was turned off on the instrument from (b)(6) 2015.There was no report of injury due to this event.

Manufacturer Narrative

Correction: outcomes attributed to adverse event (checked all that apply).[x] death [x] required intervention to prevent permanent impairment/damage (devices) above 2 outcomes checked off by mistake.There was no report of 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 industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5419935
• MDR Text Key: 37795205
• Report Number: 1217157-2016-00013
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• 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: 02/10/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention