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

Catalog Number 3002 EX

Device Problem Device Alarm System (1012)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/16/2015

Event Type  Injury  

Event Description

It was reported the patient exited the bed and fell, and the bed alarm allegedly did not sound.The patient reportedly sustained a fracture on her nose and her heart stopped briefly.The nurse did not know what bed exit zone was set but the user facility evaluated the unit after the incident and is not alleging, nor did they find, a bed malfunction.The bed was returned to service after the user facility's evaluation.

Manufacturer Narrative

The user facility performed their own evaluation on the unit involved in the alleged event.They found no malfunctions or defects, and returned the bed to service.The risk management contact indicated further evaluation was not necessary.User facility indicated no evaluation was required.

• Brand Name: SECURE II MED/SURG BED
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4516542
• MDR Text Key: 5443780
• Report Number: 0001831750-2015-00065
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2015

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?: No
• Device Operator: Other
• Device Catalogue Number: 3002 EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/13/2015
• 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