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

Catalog Number 3002 EX

Device Problems Device Inoperable (1663); Component Missing (2306); Connection Problem (2900)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/19/2014

Event Type  Injury  

Event Description

It was reported by repair work order that there was an alleged patient fall, resulting in the patient breaking their nose.The user facility called service technician to evaluate the unit only (no repairs requested).It was found that the nurse call cable was not connected, the scale display was not functional, and the footboard label to engage/disengage bed exit was missing.

Manufacturer Narrative

The issues found with the bed upon evaluation are all considered to be apparent issues, and should have precluded the unit from further use.The medwatch is being filed based on the alleged patient injury, and not due to the issues identified during the evaluation.The customer did not ask for any repairs to be made.

• 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: 4428381
• MDR Text Key: 5169518
• Report Number: 0001831750-2015-00022
• 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: 12/19/2014

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
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/16/2015
• 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