MAUDE Adverse Event Report: CARESTREAM HEALTH INC CARESTREAM Q-RAD RADIOGRAPHIC SYSTEM WITH AUTO-TRACKER OPTION; DRX-ASCEND / Q-RAD

Model Number DRX-ASCEND SYSTEM/QG-50-R10-T600

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Per the investigation, there was no device malfunction.Carestream determine this to be user caused by either (a) excessive force being applied to the table top during the transfer procedure of a large patient or (b) accidental actuation of the table foot pedals which is preventable and will not recur if the button provided on the system to disable the foot pedals is used as described in the ifu (b)(4) ("foot pedal controls for table float-top motions (foot pedal inhibit switch deactivates foot pedals to prevent inadvertent tabletop motion").Therefore the local site patient handling techniques/procedures should mitigate any injury to users/patients for the transfer of a large patient from a gurney to the radiographic table top.Simultaneously with the device, if the ifu is followed by the operator using the equipment (disabling the table foot pedal switch), this action will mitigate this type of accidental movement hazard and prevent it from leading to or resulting in a serious injury.

Event Description

Carestream health received a report related to a tech being injured during the movement/transfer of a patient from a gurney to the radiographic table top, the operator has claimed the table top moved and the brakes were not holding.Reporters narrative: table brakes not holding.Tabletop moved sideways unexpectedly while tech's were transferring a large patient from a gurney to the table.One of the tech's was injured trying make sure the patient didn't fall.

• Brand Name: CARESTREAM Q-RAD RADIOGRAPHIC SYSTEM WITH AUTO-TRACKER OPTION
• Type of Device: DRX-ASCEND / Q-RAD
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona street; rochester NY 14608
• Manufacturer (Section G): RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; building 7, no.; 1510 chuanqiao road; shanghai, 20120 6; CH 201206
• Manufacturer Contact: lee millward ; 150 verona street; rochester, NY 14608
• MDR Report Key: 8353144
• MDR Text Key: 136590819
• Report Number: 3004105475-2019-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DRX-ASCEND SYSTEM/QG-50-R10-T600
• Device Catalogue Number: 1021708
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other