MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST - DSI; TABLE, RADIOGRAPHIC, TILTING

Model Number 70643

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Head Injury (1879)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

(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

During clinical use patient was on the table and they were tilting, the table was in trendelenburg position when the strap on the footboard came out of the table and the patient slid down the table and hit her head on the floor.

Manufacturer Narrative

The easydiagnost is a fluoroscopy system.The system table can be tilted in two directions, patient head up and patient head down ("trendelenburg").In case the table is being tilted head down, the patient is prevented from falling off by shoulder rests.Additionally ankle clamps must be used if the table is being tilted (in trendelenburg) for more than 40 degrees.Customer stated that the spring that holds the ankle clamp in the footrest broke and this caused the clamp to come out.The issue cannot be caused by a broken spring, because of safety mechanism.The defect part was taken out of use and out of service.Corrected data: adverse event or product problem (changed from adverse event to product problem).Type of reportable event (changed from serious injury to malfunction).Device evaluated by manufacturer (changed from not returned to manufacturer to no).(b)(4).

• Brand Name: EASYDIAGNOST - DSI
• Type of Device: TABLE, RADIOGRAPHIC, TILTING
• 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: 5460129
• MDR Text Key: 38997603
• Report Number: 3003768251-2016-00002
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 70643
• Device Catalogue Number: 70643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other