MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 3005

Device Problem No Audible Alarm (1019)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported that a patient fell out of the bed and the bed did not alarm.It was further reported that the patient broke their hip as a result.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

The investigation is complete, b5 and section h codes have been updated to reflect investigation results.

Event Description

It was reported that a patient fell out of the bed and the bed did not alarm.The patient sustained a broken hip as a result of the fall.The patient required surgery, and was discharged afterward without any additional issues.Upon further communication with the user facility, it was determined that the bed exit was not set properly.The issue was likely not due to any component level defect or malfunction.The issue was resolved by the facility staff receiving additional training on properly setting the bed exit alarm.

• Brand Name: S3 EX - 3005
• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14595732
• MDR Text Key: 293298772
• Report Number: 0001831750-2022-00587
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3005
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2022
• 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
• Patient Outcome(s): Other