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

Catalog Number	3009PX-LE-400
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Hip Fracture (2349); Insufficient Information (4580)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device did not alarm when patient exited the bed.As a result, the patient fell and sustained an unknown injury.Attempts are being made to gather additional details from the user facility.
Additional Manufacturer Narrative
A visual and functional inspection was performed by a stryker field service technician.It was found that the clinician not alerted of the patient fall condition was not due to any component level defect of the product.It was identified that the bed exit alarm likely was not set properly.The patient egressed and fell resulting in a pelvic/hip fracture.The issue was resolved for the customer by stryker procare evaluating the unit and returning the unit to service.
Event or Problem Description
It was reported that the device did not alarm when patient exited the bed.As a result, the patient fell and sustained a hip/pelvic fracture.

• Brand Name: PROCUITY LE WITH ISOTOUR STD
• Common Device Name: 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: 17693117
• Report Number: 0001831750-2023-00993
• Device Sequence Number: 6032656
• Product Code: FNL
• UDI-Device Identifier: 07613327541182
• UDI-Public: 07613327541182
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3009PX-LE-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown