MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PCR CORADO BASIC SYSTEM; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 732026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Misdiagnosis (2159)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer complaint, that based on a stitching image patient was taken to surgery unnecessarily.

Manufacturer Narrative

Stitching of x-ray images is of interest in case of disease patterns like scoliosis or asymmetries in the structure of leg bones.The system optionally supports the automatic and manual joining of several images to produce one large image this event occurred since the operator flipped only the first image manually of the two generated images, then both were stitched together, showing a wrong composite (misaligned or broken rods in the back.) based on this stitching result, a surgery was done, no control x-ray was performed for verifying the issue.(b)(4).

Event Description

The customer complaint, that based on a stitching image, whereon broken rods for the spine was shown, patient was taken to surgery.Customer found that surgery was not needed as rods in the patients back were not broken.

• Brand Name: PCR CORADO BASIC SYSTEM
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; roentgenstr. 24; hamburg 22335 ; GM 22335 ; 405078-229
• MDR Report Key: 5379503
• MDR Text Key: 36394845
• Report Number: 3003768251-2016-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 732026
• Device Catalogue Number: 732026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other