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

Catalog Number 3002 EX

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 06/15/2017

Event Type  Injury  

Event Description

It was reported by service report that the head of bed unexpectedly lowered with a patient.A contact at the hospital stated that they believe that this event may have been attributed to accidentally pressing the cpr pedal, but that they weren't able to confirm that.It was reported that the patient went from a sitting position to lying completely flat, however they did not know the specific fowler angle.The patient alleged that they experienced back pain following the event and were prescribed dilaudid for the pain.A stryker technician evaluated the bed and could not duplicate the issue, nor was any defect or malfunction found.

• 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: 6710760
• MDR Text Key: 79944488
• Report Number: 0001831750-2017-00298
• 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
• Report Date: 07/13/2017

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: No Information
• Device Catalogue Number: 3002 EX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2007
• 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