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 Problems Fall (1848); Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 02/05/2021

Event Type  Injury  

Event Description

It was reported a patient fell off the bed onto the floor.The nurse reported the bed exit alarm was delayed and did not sound until after she heard the patient hit the ground.It was reported that the patient is currently being treated for an unknown injury.Attempts have been made to obtain injury details; however, the customer has not yet responded to these attempts.

Event Description

It was reported a patient fell off the bed onto the floor.The nurse reported the bed exit alarm was delayed and did not sound until after she heard the patient hit the ground.It was initially reported that the patient suffered an unknown injury as a result of the fall.Upon further communication, the user facility stated that the patient was being treated for a hemorrhagic stroke and suffered an additional brain bleed after the fall.The user facility was unable to determine if the additional brain bleed was a result of the fall or due to the patient's medical history.The user facility provided follow up training to their staff to ensure the bed alarms are set properly in the future.

Manufacturer Narrative

The user facility provided more details regarding the patient's injury.Section b5 has been updated to reflect this as well as the clinical signs codes in section h.H3 other text : device was evaluated by a third party.

• 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
• MDR Report Key: 11411981
• MDR Text Key: 234658449
• Report Number: 0001831750-2021-00660
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3005
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other