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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

On may 18 2017 - report failed to upload to cdhr due to duplicate report number, this error has been corrected and therefore report resubmitted.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

This report was submitted in error and the event is documented in report 1317303 -2017 -00009.

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.

• Brand Name: DRX PLUS DETECTOR
• Type of Device: DRX 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 Key: 6575643
• MDR Text Key: 75457116
• Report Number: 1317307-2017-00012
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 150766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death