MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY ZM WITH ISOTOUR PREM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3009PX-ZM-450

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that a user accelerated the device using the zoom drive and rammed into another user, causing injury.There were no issues or defects reported for the device.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

A stryker sr.Qae spoke to the stryker sales account manager, who provided that the account clarified that the injury was to the user¿s leg, and they were on leave for 10 days following the injury.Additionally, the stryker sales account manager provided that the account did not allege any deficiencies of the product.After investigation, the cause for the alleged unintended zoom resulting in user injury to the leg was likely not due to any component level defect of the product.The issue was resolved for the customer by performing in-servicing and confirming no further action was required from stryker.

Event Description

It was reported that a user accelerated the device using the zoom drive and rammed into another user, causing injury.There were no issues or defects reported for the device.

• Brand Name: PROCUITY ZM WITH ISOTOUR PREM
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17930993
• MDR Text Key: 325612547
• Report Number: 0001831750-2023-01025
• Device Sequence Number: 1
• Product Code: FNL
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3009PX-ZM-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2023
• 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
• Patient Outcome(s): Other