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

Model Number 3009PX-LEX-450

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 11/24/2022

Event Type  Injury  

Event Description

It was reported that the device's bed alarm was malfunctioning, which resulted in a patient fall.The patient was found at the foot of the bed with the iv pole penetrating her left upper extremity.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

A stryker quality assurance engineer spoke to a stryker sales account manager who provided that the device's bed exit alarm was not being set properly in their workflow.Multiple attempts were made to retrieve further information from the account surrounding the injury experienced by the patient.However, no response was received.If further information is made available, this complaint will be reopened and updated accordingly.Based on the location at the head end stryker iv pole on procuity, it was determined that the iv pole that contributed to the injury was not a stryker iv pole.Based on the available information, it was determined that the alleged clinician not alerted of possible patient fall condition which led to a patient receiving an injury was likely not due to any component level defect of the product.However, this could not be confirmed.The issue was resolved for the customer by stryker performing in-servicing to ensure the account understands the proper method to set the bed exit alarm.

Event Description

It was reported that the device's bed alarm was malfunctioning, which resulted in a patient fall.The patient was found at the foot of the bed with the iv pole penetrating her left upper extremity.

• Brand Name: PROCUITY LEX 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16064213
• MDR Text Key: 306295383
• Report Number: 0001831750-2022-01236
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541236
• UDI-Public: 07613327541236
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3009PX-LEX-450
• Device Catalogue Number: 3009PX-LEX-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• 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