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

Catalog Number 3333000000

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

It was reported by the customer that their trial unit had reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The product evaluation found the unit had damaged caster assemblies.The customer was provided with a new trial unit.

Event Description

It was reported by the customer that their trial unit had reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7786554
• MDR Text Key: 117259352
• Report Number: 0001831750-2018-00972
• 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): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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