MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 3005

Device Problem Smoking (1585)

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

Event Date 10/01/2022

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced smoke/heat.There was no patient involvement.

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; but the device was not repaired so the cause was unable to be determined.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 0 malfunction events, where it was reported the device experienced smoke/heat.There was no patient involvement.

Manufacturer Narrative

The device that was pending was evaluated and it was determined the device experienced smoke, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 1 to 0.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced smoke/heat.There was no patient involvement.

Manufacturer Narrative

This supplemental is being filed to update the method code following the completion of a device investigation.Section h codes have been updated.

• Brand Name: S3 EX - 3005
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 15674921
• MDR Text Key: 305074135
• Report Number: 0001831750-2022-01148
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• Combination Product (y/n): N
• Reporter Country Code: US
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3005
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2022
• 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