MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY, INC.; EZ STAND PREMIER 400 LB

Model Number 896

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Use of Device Problem (1670)

Patient Problems Death (1802); Fall (1848)

Event Date 04/23/2017

Event Type  Death  

Manufacturer Narrative

The only plausible cause that the nurse aide (device operator) could come up with, is that she had not properly place the loop of the sling past the safety clip on the stand.The conclusion reached by the nurse aide is the only explainable answer to how it happened, as both the lift and the sling checked out in good working order by the people at (b)(6) care center, (b)(6) of the (b)(6) department of aging and disability's, and (b)(6) of ez way, inc.

Event Description

On 05/05/2017 (b)(6) of our service department received a call from (b)(6), a nurse surveyor of regulatory with the (b)(6) department of aging and disabilities services.(b)(6) was asking for the proof of a part purchase.(b)(6) told (b)(6) there was an accident that had occurred resulting in a death at the (b)(6) care center and was following up to see that the facility had bought new safety clips.(b)(6) informed (b)(6) that the facility had made their own yellow safety clips.After receiving the call from (b)(6), (b)(6) contacted (b)(6) at (b)(6) care facility to find out more information.In an email from (b)(6) 05/05/2017 at 2:17 pm; (b)(6) description in her own words is as follows: "nurse aide had resident raised in lift.Right canvas hook came loose from pigtail hook.In re-enactment, nurse aide decided she must have not hooked it over the clip, but rather on top of the clip.That is the only way it could have slipped off while it had the resident's full weight.Lift and canvas harness were fully evaluated afterward and show no mechanical or wear/tear signs.When canvas hook came loose, resident fell and hit head on door immediately behind him.Resident was pronounced a few minutes later.".

• Brand Name: EZ WAY, INC.
• Type of Device: EZ STAND PREMIER 400 LB
• Manufacturer (Section D): EZ WAY, INC.; 710 e. main st.; clarinda IA 51632
• Manufacturer (Section G): EZ WAY, INC.; 710 e. main st.; clarinda IA 51632
• Manufacturer Contact: jeffrey clark ; 710 e. main st.; clarinda, IA 51632 ; 7125425102
• MDR Report Key: 6607424
• MDR Text Key: 76501630
• Report Number: 2183887-2017-00001
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: 896
• Device Catalogue Number: S400PN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 79