ENDURA GLIDER UNK 260911

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-23 for ENDURA GLIDER UNK 260911 manufactured by Unk.

Event Text Entries

[132315] A 43-year-old male patient attempted suicide by hanging self on bathroom doorknob on psych unit, using a black strap. The strap appears to be identical to the straps which are tied to the endura glider transport boards in the radiologhy dept. The patient had been to radiology for x-rays on the morning of the suicide attempt. When the patient was found, there was a pulse but no respirations. Cardiopulmonary resuscitation started, and patient began spontaneous respirations. Patient was admitted to cardiac care unit, and on a ventilator until 2/19/99 when he was removed from ventilatory and breating on his own.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	211615
MDR Report Key	211615
Date Received	1999-02-23
Date of Report	1999-02-22
Date of Event	1999-02-15
Date Facility Aware	1999-02-15
Report Date	1999-02-22
Date Reported to FDA	1999-02-22
Date Reported to Mfgr	1999-02-22
Date Added to Maude	1999-03-02
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	0
Reporter Occupation	RISK MANAGER
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	ENDURA GLIDER
Generic Name	TRANSPORT BOARD
Product Code	KNL
Date Received	1999-02-23
Model Number	UNK
Catalog Number	260911
Lot Number	NA
ID Number	NA
Operator	NOT APPLICABLE
Device Availability	Y
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	205364
Manufacturer	UNK
Manufacturer Address	UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	1999-02-23