MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 HIGHPERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712034

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Laceration(s) (1946); Skin Tears (2516)

Event Date 06/03/2021

Event Type  Injury  

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 reported that a patient was harmed when getting off the patient table of an digitaldiagnost c90.He cut himself in the foot on the "centering device".The centering device unit is to measure the position of the detector.The cut resulted in seven stitches.

Manufacturer Narrative

Int.Ref.: (b)(4).In digitaldiagnost systems, there are two types of detectors: portable and fixed.The portable skyplate detectors can be used for free exposures and can be removed from the bucky unit.The fixed detectors are permanently installed in the bucky unit subsystem.The bucky unit for fixed detectors has a metal center indicator which is used to locate the center of the detector when direct view is blocked by the table.This facilitates proper patient positioning in relation to the detector and the tube assembly so that the anatomy of interest is centered upon image.The center indicator is located on the bottom of the bucky unit and protrudes approximately 6 mm from the front panel for ease of access.During use, the center indicator is swung out of its parking position so that it is positioned parallel to the floor and extended from the table.The customer reported taking free exposures of a patient's hand/finger with the portable skyplate detector.The skyplate detector was placed on the table directly above the fixed bucky unit.The patient was positioned in front of the table with his/her legs facing the table base with the fixed bucky unit.For the final projection, the patient was asked to turn to his left side.While turning, the patient made contact with the parked center indicator resulting in a cut to the patient¿s knee.The cut required medical attention.The investigation revealed that there was no system malfunction.The patient's injury was exacerbated due to the patient positioning.Free exposure of a patient may occur, although less common than with use of the fixed bucky unit, and is anticipated for imaging of smaller anatomy (i.E.Hand or elbow).The conventional patient positioning under this scenario has the patient sitting near the short side of the table as this provides sufficient room for the patient¿s knee.During this hazardous situation, the patient was positioned in proximity to the center of the table, where the foot switches for table movement and the center indicator are located.The suboptimal patient positioning resulted in the inadvertent patient injury.As a result, the customer decided to remove the centering indicator and use the tray drive function for alignment purposes only.Risk estimation determined that no unacceptable risk was present.Going forward, the issue shall be 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: h1 from seroíous injury to injury.H6 patient, result and conclusion code.

• Brand Name: DIGITALDIAGNOST C90 HIGHPERFORMANCE
• 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: 11998239
• MDR Text Key: 256161065
• Report Number: 3003768251-2021-10006
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: 00884838090699
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K182973
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 712034
• Device Catalogue Number: 712034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/03/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 02/02/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male