MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE CONNECT LOCATOR; BED, AC POWERED ADJUSTABLE

Catalog Number 521200380100

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.

Manufacturer Narrative

The 2 devices that were pending received more information that the power cords were missing making this loss of electric function which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 2 to 0.

Event Description

This report summarizes 0 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.

• Brand Name: SECURE CONNECT LOCATOR
• Type of Device: BED, AC POWERED ADJUSTABLE
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17378210
• MDR Text Key: 319599620
• Report Number: 0001831750-2023-00926
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327520453
• UDI-Public: 07613327520453
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 521200380100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2023
• 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