MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH HORIZONTALDIAGNOST H; SYSTEM, X-RAY, STATIONARY

Model Number 70404

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

The customer reported that the "lbd casing is hanging off".Based on the information received to date, the collimator assembly (also known as bld (beam limiting device)) had come loose from its flange.The system was not in clinical use at that time.

Manufacturer Narrative

This event is still under investigation.A follow up report will be submitted upon completion of the investigation.(b)(4).

Manufacturer Narrative

The collimator is used to delimit the x ray field to the region of interest and is connected to the ceiling suspension.The field service engineer found the collimator assembly flange was loose.The system was not in clinical use at that time.The cover of this collimator type is designed to prevent a drop of the collimator even if the flange is loose.The field service engineer removed the collimator and cleaned up both sides of the flange and collimator.After the collimator was remounted, the system is working as specified.No further actions required.(b)(4).

• Brand Name: HORIZONTALDIAGNOST H
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 2233 5; GM 22335
• Manufacturer Contact: deborah thurston ; roentgenstr. 24; hamburg 22335 ; GM 22335 ; 405078-229
• MDR Report Key: 4577137
• MDR Text Key: 5450288
• Report Number: 3003768251-2015-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70404
• Device Catalogue Number: 70404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2015
• 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