• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH INC DRX PLUS DETECTOR DRX DETECTOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARESTREAM HEALTH INC DRX PLUS DETECTOR DRX DETECTOR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The current facts available indicate that this incident was not the result of a malfunction of the carestream drx plus detector. Per the hospital, their technologist incorrectly positioned the detector in relation to the thumper which interfered with battery function and caused the loss of power to the detector. Carestream health (csh) has initiated a formal investigation into this incident that will be managed through the csh capa system. A follow up report will be submitted to the fda as soon as additional facts are available.
 
Event Description
Customer alleges the following: a patient was on the table with the drx plus detector between a thumper (mechanical heart compression device; not manufactured or supplied by carestream health and the patient. The patient died on the table with the detector under the patient while the technologist was in the process of trying to take an exposure. The exposure was not able to be taken due to loss of power to the detector.
 
Manufacturer Narrative
(b)(6). The current facts available indicate that this incident was not the result of a malfunction of the carestream drx plus detector. Per the hospital, their technologist incorrectly positioned the detector in relation to the thumper which interfered with battery function and caused the loss of power to the detector. Carestream health (csh) has initiated a formal investigation into this incident that will be managed through the csh capa system. A follow up report will be submitted to the fda as soon as additional facts are available. Carestream health (csh) mdr 1317307 2017 00009 was erroneously submitted on 09-may-2017 as a 5 day report. This report should have been submitted as a 30 day as csh was not required to initiate action to prevent an unreasonable risk of substantial harm.
 
Event Description
Customer alleges the following: a patient was on the table with the drx plus detector between a thumper (mechanical heart compression device; not manufactured or supplied by carestream health and the patient. The patient died on the table with the detector under the patient while the technologist was in the process of trying to take an exposure. The exposure was not able to be taken due to loss of power to the detector.
 
Manufacturer Narrative
The root cause was found to be pinching of the wire between a metal post (boss) and the rear cover of the detector. The wire was most likely on top of the post since the unit was manufactured and possibly slipped on top of the post when the rear port gasket was being installed. There are no immediate or long range health consequences associated with the use of this device. If the detector loses power, an alternative imaging device or modality may be needed. This failure mode was addressed in the product hazard risk analysis (phra) and risk mitigation (as detailed in the phra) was found to be acceptable. This issue was evaluated by carestream environmental health and safety and found not to present an electrical or thermal hazard. As noted in the complaint, the patient associated with this incident expired. However, the site indicated that the patient was dead before images were attempted. The patient had not been declared dead, so it is hospital protocol in these situations to image the patient to determine placement of a tube (in the patient). The failure of the detector did not contribute to the death of the patient.
 
Event Description
Customer alleges the following: a patient was on the table with the drx plus detector between a thumper (mechanical heart compression device; not manufactured or supplied by carestream health and the patient. The patient died on the table with the detector under the patient while the technologist was in the process of trying to take an exposure. The exposure was not able to be taken due to loss of power to the detector.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRX PLUS DETECTOR
Type of DeviceDRX DETECTOR
Manufacturer (Section D)
CARESTREAM HEALTH INC
150 verona st
rochester NY 14608
Manufacturer (Section G)
STC
5450 campus drive
canandaigua NY 14424
Manufacturer Contact
michael callery
MDR Report Key6555395
MDR Text Key74768928
Report Number1317307-2017-00009
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
150766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Radiologic Technologist
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
-
-