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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO PROCUITY; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 300900000000
Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2023
Event Type  malfunction  
Event Description
It was reported that the something is wrong with the devices scale, possible indicating measured weight inaccurate.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the something is wrong with the devices scale, possible indicating measured weight inaccurate.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
A visual and functional inspection was performed, and the issue identified is not reportable.The record was updated to reflect the model number and serial number.The associated complaint will be closed as a duplicate of the work order.
 
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Brand Name
PROCUITY
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
marleca lane
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key18470852
MDR Text Key332740044
Report Number0001831750-2024-00006
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 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
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 Received12/11/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2021
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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