ELECTRIC HIGH/LOW TILT TABLE 2340 HLT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for ELECTRIC HIGH/LOW TILT TABLE 2340 HLT * manufactured by Midland Manufacturing Co..

Event Text Entries

[18438695] Pt placed in tilt table with straps secured. Tilt table raised to 45 degrees at which point the entire table fell over with the pt still in it. Unit fell over to the right side. Pt in coma so it is difficult to determine if she is in pain; no response ilicited with palpation or manipulation of joints. No bruises, abrasions, edema or erythema noted. Unalbe to determine if pt struck head. Ct scan of head ordered with negative. Physician indicates he may order add'l x-rays. Biomedical engineering found 7 screws missing from one end of table and physical therapist found 2 screws on floor. Add'l investigation initiated. Wgt limit of unit = 275 lbs, pt wgt 213 lbs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1010453
MDR Report Key	57632
Date Received	1996-12-23
Date of Report	1996-12-19
Date of Event	1996-12-18
Date Added to Maude	1996-12-26
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	ELECTRIC HIGH/LOW TILT TABLE
Generic Name	X-RAY TABLE
Product Code	JFB
Date Received	1996-12-23
Model Number	2340 HLT
Catalog Number	*
Lot Number	*
ID Number	*
Operator	OTHER
Device Availability	Y
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	58122
Manufacturer	MIDLAND MANUFACTURING CO.
Manufacturer Address	802 UNIVERSAL DR COLUMBIA SC 29209 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-12-23