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

Model Number 712022

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported that he has problems with the gas spring fixation of the patient support for stitching.No injury occured.

Manufacturer Narrative

Ref.Id: (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.

Manufacturer Narrative

Ref.Id: (b)(4).The digitaldiagnost 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 philips healthcare field service engineer (fse) has investigated at site and confirmed reported problem.The cause was not identified.However the capa and fco investigation concluded that breaking of the mounting of the brake cylinder can only result if a person stepped onto the footplate to force the down movement before it was fully released on the floor.The field service engineer fixed the fixing bolt of the gas spring by moving it slightly to the side.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.Correction: h6 result and conclusion.

• Brand Name: DIGITALDIAGNOST DUAL 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15360389
• MDR Text Key: 305493876
• Report Number: 3003768251-2022-00007
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• 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: 712022
• Device Catalogue Number: 712022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 11/04/2022
• 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