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

Catalog Number	5700000000
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bed exit failed to alarm when a patient with pre-existing fractures got out of the bed.The patient fell and examination afterward identified that the patient had sustained spinal fractures, although the age of the fractures could not be definitively identified.
Additional Manufacturer Narrative
The imdrf codes and b5 summary have been updated to reflect the findings of the completed investigation.
Event or Problem Description
It was reported that the bed exit failed to alarm when a patient with pre-existing fractures got out of the bed.The patient fell and afterwards underwent a thoracic spine ct without contrast.The patient was found to have had indeterminate age compression fractures of t5, t10, and t12.It could not be determined if the fractures were caused by the fall.

• Brand Name: SPIRIT SELECT
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22012317
• Report Number: 0001831750-2025-00696
• Device Sequence Number: 14750603
• Product Code: FNL
• UDI-Device Identifier: 07613327284546
• UDI-Public: (01)07613327284546
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/02/2025

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: 5700000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2020
• 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