MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST HYDRAULIC GURNEY MODEL 21762 PS TECH; STRETCHER, WHEELED

Model Number 21762

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

Customer reported to sechrist service tech, that the patent safety rail is broken and needs to be replaced.Additional information received, found the gurney was being used with a patient.When the patient grabbed the side rail to pull themselves up, the rail broke.There was no injury to the patient.

Manufacturer Narrative

During service repair of the gurney, field service technician confirmed the side rail was broken.Siderail was replaced and the gurney was left in working condition.In an attempt to get additional information about the malfunction, it was discovered, that at the time of the event, the siderail was loose but would still latch.The rail has 5 vertical bars that hold it to the base, one of the bars broke from the rail, not the one that latched, and the user continued using it.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file no.(b)(4).

• Brand Name: SECHRIST HYDRAULIC GURNEY MODEL 21762 PS TECH
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 13387310
• MDR Text Key: 295609202
• Report Number: 2020676-2022-00003
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21762
• Device Catalogue Number: 21762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• 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