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

Catalog Number 3005S3EX

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.23 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 24 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.

• 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: 17407142
• MDR Text Key: 320160927
• Report Number: 0001831750-2023-00946
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 24
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• 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