EZSLIDE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-29 for EZSLIDE * manufactured by Skytron.

Event Text Entries

[3868240] A patient was having a muscle sparing bipolar hip replacement, anterior approach, when the surgeon asked to have the foot of the bed lowered. The crna lowered the foot of the bed. The foot dropped quicker than the surgeon liked, and commented that the quick lowering could have caused a fractured hip/pelvis for the patient. The bed was removed from service after the surgery was over. Biomed was called and informed of the incident, as was the company that manufactures the bed. The setting on the table was two seconds quicker than the normal 15 seconds, but 13 seconds is still within specs. The service rep adjusted the setting to 15 seconds as per the service manual. This was completed today.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3354118
MDR Report Key	3354118
Date Received	2013-07-29
Date of Report	2013-07-29
Date of Event	2013-07-24
Report Date	2013-07-29
Date Reported to FDA	2013-07-29
Date Reported to Mfgr	2013-09-18
Date Added to Maude	2013-09-18
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	EZSLIDE
Generic Name	TABLE AND ATTACHMENTS, OPERATING-ROOM
Product Code	BWN
Date Received	2013-07-29
Model Number	EZSLIDE
Catalog Number	*
Lot Number	*
ID Number	*
Operator	NURSE
Device Availability	Y
Device Age	*
Device Sequence No	1
Device Event Key	0
Manufacturer	SKYTRON
Manufacturer Address	5085 CORPORATE EXCHANGE BLVD. GRAND RAPIDS MI 49512 US 49512

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-29