MAUDE Adverse Event Report: GF HEALTH PRODUCTS INC. ZENITH I; BED

Model Number 508-1740-OL4000

Device Problem Unintended Collision (1429)

Patient Problems Death (1802); Laceration(s) (1946)

Event Date 08/30/2020

Event Type  Death  

Manufacturer Narrative

Gf health products, inc.Has inspected the device at the user facility location and found it to be in good working order and functioning as intended.User facility has agreed to release the bed to gf health products, inc.For additional evaluation once their investigation is complete.A follow -up report will be sent in the event the product subject to this adverse event is released and additional testing/analysis is performed.

Event Description

Resident was found on the floor perpendicular to the bed frame in a supine position with the bed hand controller (pendant) under his body.The back of the resident's head was located on top of the lower center bed frame.The upper frame and sleep deck lowered onto the residents head causing a laceration running from resident's left temple across the forehead just above the eyebrows and ending at the right temple.Ariticulation of the bed hi/lo mechanism was the result of the resident falling/sitting/laying on the hand controller when he left the sleep surface.

• Brand Name: ZENITH I
• Type of Device: BED
• Manufacturer (Section D): GF HEALTH PRODUCTS INC.; 336 trowbridge drive; fond du lac, wi
• Manufacturer (Section G): GF HEALTH PRODUCTS, INC.; 336 trowbridge drive; fond du lac, wi
• Manufacturer Contact: amy piccini ; one graham field way; atlanta, ga ; 2913282
• MDR Report Key: 10494801
• MDR Text Key: 205702066
• Report Number: 2428983-2020-00002
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/04/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 508-1740-OL4000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2004
• 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): Death
• Patient Age: 83 YR
• Patient Weight: 70