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 Problems Loose or Intermittent Connection (1371); Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

Int.Ref.: (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 complaint that wall bucky stand is out of alignment.Stand mounting bolts are loose.

Manufacturer Narrative

Int.Ref.: (b)(4).The digitaldiagnost dual detector is a stationary x-ray system for general radiographic purposes.It is equipped with a wall stand (¿vertical stand¿ vs), with a digital detector inside a bucky unit.The wall mounted stand is fixed to the wall and to the floor with screws.Philips field service engineer investigated at site.He found that the x-ray tube at the ceiling suspension and the detector inside the wall bucky were no longer properly aligned, because the fixation screws at the wall stand were slightly loose.The cause were most likely loosened from patients bumping into bucky unit over time.Philips field service engineer tightened the screws at wall and floor.With this action the misalignment was also fixed.The system works as specified after this intervention.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.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 DUAL DETECTOR
• 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: 8802763
• MDR Text Key: 151616362
• Report Number: 3003768251-2019-00011
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K090625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 712022
• Device Catalogue Number: 712022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1