MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712020

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 digitaldiagnost single 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 (9890 010 87431), 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 philips healthcare field service engineer (fse) has investigated at site and found the frame damaged (cast aluminum was broken).The cause was not identified but most probable a person stepped onto the footplate to force down movement before it was fully released on the floor.The fse has replaced the patient support for stitching.System works as specified again.A capa investigation was conducted with the result of acceptable risk per benefit risk determination.This issue is further monitored and trended.

Event Description

The customer complained that the mounting of the brake cylinder at the patient support for stitching failed.No patient or user harmed.

• Brand Name: DIGITALDIAGNOST SINGLE DETECTOR
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• MDR Report Key: 12175680
• MDR Text Key: 261780192
• Report Number: 3003768251-2021-10010
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K090625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 712020
• Device Catalogue Number: 712020
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/14/2021
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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