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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30; MATTRESS, FLOTATION THERAPY, NON-POWERED
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STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 1704034300
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2018
Event Type  malfunction  
Event Description
It was reported that the mattress slides off from the stretcher during patient transfers from the operating room table to the stretcher.The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was reported that the user facility had experienced issues with the mattress allegedly sliding off the stretcher during patient transfers and that the customer was not satisfied with the velcro design.No product defect was alleged.This issue was resolved for the customer by having the customer trial a different style of mattress that will better align with their needs.
 
Event Description
It was reported that the mattress slides off from the stretcher during patient transfers from the operating room table to the stretcher.The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
ULTRA COMFORT, SE 4 X 30
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7510844
MDR Text Key108267481
Report Number0001831750-2018-00477
Device Sequence Number1
Product Code IKY
UDI-Device Identifier07613327298567
UDI-Public(01)07613327298567
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 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1704034300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/17/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received04/17/2018
Supplement Dates FDA Received07/03/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2017
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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