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

Catalog Number 300900000000

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that the patient was walking around the foot of the bed and tripped/fell on the bottom corner of a down side rail.The patient landed on their bottom/left hip, but there was no serious injury reported.

Manufacturer Narrative

Based on the information provided, a stryker senior quality assurance engineer determined that the alleged bed protruding/obstructing, resulting in a tripping hazard, was likely not due to any component level defect of the bed.Rather, it is likely that the bed was in the lowest position and the patient (reported to have dementia/elopement risk) was not fully aware of their surroundings.However, this product was not made available for further stryker evaluation so this could not be confirmed.The issue was resolved for the customer by documenting the complaint and confirming no further action was required from stryker.

Event Description

It was reported that the patient was walking around the foot of the bed and tripped/fell on the bottom corner of a down side rail.The patient landed on their bottom/left hip, but there was no serious injury reported.

• Brand Name: PROCUITY
• 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: 17723769
• MDR Text Key: 323173992
• Report Number: 0001831750-2023-01003
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 300900000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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