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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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 unexpectedly.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 system supports general radiographic imaging.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 "patient support for stitching".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 footboard from falling.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard fell down immediately.In a worst case, it may hit the foot of a person and break a bone.Philips field service engineer confirmed that the brake cylinder had broken out of the frame of the patient support for stitching.The cause of the issue was identified to wrong use of patient stitching support by the patient.The customer denied philips support and decided to repair the device himself.The customer is aware that philips can take no responsibility for that repair and its potential consequences.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: 11292439
• MDR Text Key: 230702320
• Report Number: 3003768251-2021-00002
• 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: foreign,health professional
• 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?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 07/14/2021
• 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