MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EASY DIAGNOST ELEVA DRF; TABLE, RADIOGRAPHIC, TILTING

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Physical Entrapment (2327)

Event Date 06/26/2014

Event Type  No Answer Provided  

Event Description

The patient was prone on the fluoro table, crossed arms up (tucked under pillow) with the patient's head resting on the pillow.The fluoro table was moved back to the original position.The patient cried out in pain.The patient's skin on forearm was pinched between the table and the movable table top.The patient experienced an abrasion and bruising of the left forearm.The area was examined, cleaned and bandaged.

• Brand Name: EASY DIAGNOST ELEVA DRF
• Type of Device: TABLE, RADIOGRAPHIC, TILTING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 4100706
• MDR Text Key: 4760245
• Report Number: 4100706
• Device Sequence Number: 1
• Product Code: IZZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 74 YR