MAUDE Adverse Event Report: DIGITALDIAGNOST CLASSIC; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712050

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Int.Ref.(b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

The customer complained that the brake cylinder broke out of the frame of the patient support for stitching.The brake cylinder prevents the footboard of the patient support for stitching from falling down unexpected.A falling footboard can lead in worst case to a fracture in the foot.No injury occurred.

Manufacturer Narrative

Int.Ref.(b)(4).The digitaldiagnost dual detector is a direct digital radiography system with flat detector technology based on modular components to allow for customization for all radiographic applications and workload requirements.For anatomies that are larger than the detector size, it is possible to make a series of exposures covering the whole anatomy (for example full spine or full legs).These individual images can be "stitched" together via the software program.For proper patient positioning and support, the patient can be placed on the so called stitching patient support or patient support for stitching, a platform with two handles that the patient can hold on to during the examination.For the ease of use during transportation, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a brake cylinder.It has to be folded up and fixed by a hook for transportation, e.G.From one room to another.The brake cylinder has the task to ensure that the footboard lowers itself slowly (within 5-7 seconds) when the hook is released, to prevent the footplate from falling on the foot of a person.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard falls down immediately.In a worst case, it may hit the foot of a person and break a bone.The exact cause for the issue is unknown.However the capa and fco investigation concluded that breaking of the mounting of the brake cylinder can only result from abnormal use.A quote has been provided to te customer for the repair of the patient support for stitching.But the customer refused the quote and access to the affected device.Based on no response from the customer it is unknown if the patient support for stitching is still in use or has been repaired by a third party.The digitaldiagnost system will continue to fulfil intended use.A capa investigation was conducted with the result of acceptable risk per benefit risk determination.This issue is further monitored and trended.

• Brand Name: DIGITALDIAGNOST CLASSIC
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• MDR Report Key: 12075582
• MDR Text Key: 258646842
• Report Number: 3003768251-2021-10008
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K982795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 712050
• Device Catalogue Number: 712050
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/16/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No
• 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