MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TRURIZE; CHAIR, POSITIONING, ELECTRIC

Model Number 3333

Device Problem Mechanical Problem (1384)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced reduced/inadequate brake force.There was no patient involvement.

• Brand Name: TRURIZE
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: kaitlyn matheny ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12233948
• MDR Text Key: 264055070
• Report Number: 0001831750-2021-01058
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 07613327322569
• UDI-Public: 07613327322569
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3333
• Device Catalogue Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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