MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE 3 MED/SURG BEDOBS 01/13; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3002S3EX

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

The user facility evaluated their device.

Event Description

It was reported that the alarm did not sound when a patient fell from the bed.The user facility performed their own evaluation and later met with a stryker field service technician.The user facility determined that there were no defects with the bed and believe the caregiver did not check all of the cables to make sure they were plugged in properly.The stryker field service technician was told that the patient suffered a hip fracture; however, further injury details are still being gathered.

Manufacturer Narrative

The user facility provided further details regarding the injury.Section h codes and b5 have been updated.

Event Description

It was reported that the alarm did not sound when a patient fell from the bed.The user facility performed their own evaluation and later met with a stryker field service technician.The user facility determined that there were no defects with the bed and believe the caregiver did not check all of the cables to make sure they were plugged in properly.Upon follow up with the user facility it was found that patient suffered a right femoral fracture and needed surgery to treat it.

• Brand Name: SECURE 3 MED/SURG BEDOBS 01/13
• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12823057
• MDR Text Key: 280845081
• Report Number: 0001831750-2021-01630
• 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: 01/31/2022

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: 3002S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 01/31/2022
• 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): Required Intervention; Other