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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY BED; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO PROCUITY BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 300900000000
Device Problem No Audible Alarm (1019)
Patient Problem Fall (1848)
Event Date 12/14/2022
Event Type  malfunction  
Event Description
It was reported that the bed alarm is taking too long to set so users are leaving the patient room before the alarm has set.It was further reported that this is causing patient falls, but no adverse events have been reported.Attempts are being made to gather additional details from the user facility.
 
Manufacturer Narrative
Through communication with the stryker sales account manager, there is no issue related to any functionality deficit of the product, but rather the nursing staff was not educated properly on how the product functions.The issue was resolved for the customer by stryker performing in-servicing to teach staff how to properly ensure the bed exit alarm is set before leaving a patient unattended.
 
Event Description
It was reported that the bed alarm is taking too long to set so users are leaving the patient room before the alarm has set.It was further reported that this is causing patient falls, but no adverse events have been reported.
 
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Brand Name
PROCUITY 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
melissa millard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key16147756
MDR Text Key307191710
Report Number0001831750-2023-00002
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number300900000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/14/2022
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 Number1
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