MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKYDIAGNOST CEILING SYSTEM (CS)

Model Number 704031

Device Problems Unintended System Motion (1430); Detachment of Device or Device Component (2907)

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

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 reported that the board of patient support cannot be fixed.No injury reported.

Manufacturer Narrative

Ref.Id: (b)(4).The buckydiagnost is a analog radiography system equipped with a ceiling suspended column (carrying the x-ray tube), bucky table and bucky wall stand for general x-ray examinations.The bucky table is a height adjustable table with floating table top for easy horizontal and vertical patient positioning with a large movement range.The floating table top is equipped with electromagnetic brakes which are active when power is applied.The brakes can be released for patient positioning by foot switch or optional hand switch.Phips field service engineer visited the customer site.During the investigation, it was discovered that the bucky table could not be locked and was floating.The bucky table top was not locking due to microswitch problem in the foot pedal.Phips field service engineer adjusted the microswitch.After which, the system works as specified again.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.

• Brand Name: BUCKYDIAGNOST CEILING SYSTEM (CS)
• Type of Device: BUCKYDIAGNOST CEILING SYSTEM (CS)
• 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: 12802282
• MDR Text Key: 280705521
• Report Number: 3003768251-2021-10014
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K945278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 704031
• Device Catalogue Number: 704031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2021
• 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