MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION TOSHIBA; FLUOROSCOPIC X-RAY SYSTEM

Model Number INFINIX CF-I/BP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Physical Entrapment (2327)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that a technician's right hand was pinned between the lateral camera flat panel detector and the arm that supports it.It allegedly occurred as the technician was placing a protective sterile bag over the detector at the beginning of a procedure.The customer stated that it appeared that the pressure of the bag itself activated the safety feature that moves the lateral camera away from the patient.The system (lateral camera) performed as intended as far as moving backwards to protect the patient from impact, but the technician's right hand was behind it at the time.The customer also stated that the technician's hand was pinned for approximately 5 to 7 seconds while she was searching for the button to move the camera away.There were no fractures to the technician's hand, just a little swelling around the wrist area and a small abrasion from pulling her hand out.The manufacturer has investigated the incident and has determined the cause is user error.The operation manual contains a warning about getting hands caught as follows: "be careful to prevent hands from being caught in moving sections of the support unit or catheterization table.In particular, special care must be taken to ensure that hands are not caught between the fpd and the fpd support section cover or between the c-arm and the c-arm support section.".

Event Description

A technician's right hand was pinned between lateral camera flat panel detector and the arm that supports it.

• Brand Name: TOSHIBA
• Type of Device: FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 5780734
• MDR Text Key: 49127406
• Report Number: 2020563-2016-00004
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INFINIX CF-I/BP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other