MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4 HIGH PERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712027

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 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

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)(6).The digitaldiagnost is a direct digital radiography system with flat detector technology based on modular components to allow customization for all radiographic applications and workload requirements for anatomies that are larger than the detector size like scoliosis, 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 or stitching stand, 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.Philips field service engineer visited the customer site.The mounting of brake cylinder was not broken.The brake cylinder has become detached from the stitching stand.The cause of this issue is most probably wear and tear.Philips field service engineer replaced the whole patient support for stitching for a newer version.System works as specified.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.Correction: h6 result and conclusion.

• Brand Name: DIGITALDIAGNOST 4 HIGH PERFORMANCE
• 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: 13018355
• MDR Text Key: 282342996
• Report Number: 3003768251-2021-10018
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141736
• 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: 712027
• Device Catalogue Number: 712027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 04/07/2022
• 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