MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX4-3005; BED, AC-POWERED, ADJUSTABLE HOSPITAL

Model Number 3005

Device Problem No Audible Alarm (1019)

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

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported that the bed did not alarm and a patient fell.The patient sustained a non-displaced fracture in their left femoral neck.As a result of the fracture, the patient had a left hip arthroplasty.Upon evaluation, no defect was identified with the bed.

• Brand Name: S3 PX4-3005
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13501764
• MDR Text Key: 285704019
• Report Number: 0001831750-2022-00248
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278422
• UDI-Public: 07613327278422
• 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
• Report Date: 02/09/2022

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 Model Number: 3005
• Device Catalogue Number: 3005S3PX4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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