MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR; SYSTEM, X-RAY, STATIONARY

Model Number 712020

Device Problem Component Falling (1105)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Event Description

Philips received a complaint that during positioning for a lateral chest examination, the digital detector fell down to the floor.The pt's foot got scratched, no treatment was required.

Manufacturer Narrative

The investigation is still on going on this event.When the investigation is completed a follow up report will be sent.(b)(4).

Manufacturer Narrative

Two bolts ensure that the tilt module cannot be lifted out of the anchorage.These two fixation screws preventing the unit to slide off were missing.The issue can happen, if installation and preventive maintenance is not executed as intended.The correct placement of these bolts is content of a warning label in the installation manual and is supposed to be checked during preventive maintenance, this is required once per year (the fixation of the bucky module is a checkpoint in the service documents).This system was installed by a dealer, not by philips service.The customer did not sign a service contract with philips.During annual preventive maintenance any loose or missing screw would have been recognized.In the reported case no adequate preventive maintenance was performed.After adding the screws by a philips service engineer, the system worked as specified again.Philips local service advised the field service engineers dealing with the digital radiography installation of proper installation.(b)(4).

• Brand Name: DIGITALDIAGNOST SINGLE DETECTOR
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH; roentgenstrasse 24; hamburg 2233 5; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 2233 5; GM 22335
• Manufacturer Contact: dominic siewko ; 3000 minuteman rd; ms 4-235; andover, MA 01810 ; 9786597836
• MDR Report Key: 4109541
• MDR Text Key: 4696518
• Report Number: 3003768251-2014-00013
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

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: 712020
• Device Catalogue Number: 712020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 09/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2015
• 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: Initial
• Patient Sequence Number: 1