MAUDE Adverse Event Report: DEL MEDICAL, INC VS300; RADIOGRAPHIC CASSETTE HOLDER

Model Number VS300

Device Problem Material Torqued (2980)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

Only parts were returned.

Event Description

The counter weight bolt broke from the counter weight in a radiographic cassette holder and the receptor fell to the floor.There were no injuries reported.

• Brand Name: VS300
• Type of Device: RADIOGRAPHIC CASSETTE HOLDER
• Manufacturer (Section D): DEL MEDICAL, INC; 241 covington drive; bloomingdale IL 60108
• Manufacturer (Section G): DEL MEDICAL, INC; 241 covington drive; bloomingdale IL 60108
• Manufacturer Contact: william kostecki ; 241 covington drive; bloomingdale, IL 60108 ; 8472887022
• MDR Report Key: 5156277
• MDR Text Key: 28852650
• Report Number: 1418964-2015-00001
• Device Sequence Number: 1
• Product Code: IXY
• 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
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: VS300
• Device Catalogue Number: 110-5124G3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1418964-10/14/15-001-C
• Patient Sequence Number: 1