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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 RP 500 Back to Search Results
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.

 
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Brand NameRAPIDPOINT 500
Type of DeviceRP 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 Key5419935
MDR Text Key37795205
Report Number1217157-2016-00013
Device Sequence Number1
Product Code KQO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113216
Number of Events Reported1
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 Received02/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER HEALTH CARE PROFESSIONAL
Device Catalogue Number10492730
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/09/2016 Patient Sequence Number: 1
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