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

Model Number 3333

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.1 device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.2 devices were not evaluated and no cause was determined, as the customer did not make the devices accessible for testing.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 3 malfunction events, where it was reported there was an alarm malfunction.There was one instance where a patient fell from the bed, but the patient did not experience any adverse consequences.

Manufacturer Narrative

1 reported event was initially reported as a malfunction, where the patient fell with no consequences.Stryker later received (b)(4) from the facility informing the patient sustained a serious injury.Section b5 has been updated to indicate this report captures 2 events, not 3.

Event Description

This report summarizes 2 malfunction events, where it was reported there was an alarm malfunction.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
• MDR Report Key: 10004637
• MDR Text Key: 189180041
• Report Number: 0001831750-2020-00494
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 07613327322569
• UDI-Public: 07613327322569
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1