MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH TRAUMADIAGNOST

Model Number 72001

Device Problem Component Falling (1105)

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

Event Type  malfunction  

Event Description

Philips received a report from a customer that th trauma arm of the ceiling suspension fell down onto the table by its own while the system was not in use.No pt or user injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

The tube is mounted together with a cassette holder to the ceiling suspension telescope arm (trauma support block), which allows easy positioning in horizontal and vertical direction.Tube and cassette holder have a fixed relative position via the so-called trauma arm that can be rotated.Investigation showed that 2 of the 3 trauma support block fixing screws cracked out of its thread and the third screw sheared off.Nobody was in the examination room at the moment the trauma arm fell down onto the table.The field service engineer exchanged the affected shaft and 3 new fixing screws.Philips will publish a field safety corrective action regarding this problem ((b)(4)) in august 2015.(b)(4).

• Brand Name: TRAUMADIAGNOST
• 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: deborah thurston ; 3000 minuteman rd ; andover, MA 01810 ; 9786592010
• MDR Report Key: 4262169
• MDR Text Key: 5008850
• Report Number: 3003768251-2014-00016
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K945278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/22/2014

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: 72001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/06/2014
• 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