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

Model Number 712050

Device Problem Break (1069)

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

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 unexpected.A falling footboard can lead in worst case to a broken big toe.

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 customer reported that the problem happened during normal usage, user did not step on the footboard.The capa and fco investigation concluded that breaking of the cylinder can only result from abnormal use, so if the stand is used as intended there is no risk.A capa investigation was conducted with the result of acceptable risk per risk benefit determination.The customer did not agree to the repair or the replacement of the unit by philips.Therefore it can be concluded that the customer accepts the condition of patient support for stitching and is therefore responsible for the use of patient support for stitching.This issue is further monitored and trended.Correction: h6 result and conclusion.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: DIGITALDIAGNOST
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 9075479
• MDR Text Key: 163962340
• Report Number: 3003768251-2019-00017
• 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
• Report Date: 09/03/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1