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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BASSINET, TRADITIONAL STYLE; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO BASSINET, TRADITIONAL STYLE; STRETCHER, WHEELED Back to Search Results
Model Number 4400
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; there was a broken/damaged component.The device was repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the tub was broken.There was no patient involvement.
 
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Brand Name
BASSINET, TRADITIONAL STYLE
Type of Device
STRETCHER, WHEELED
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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key9634066
MDR Text Key176663680
Report Number0001831750-2020-00049
Device Sequence Number1
Product Code NZG
UDI-Device Identifier07613327169256
UDI-Public07613327169256
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4400
Device Catalogue Number4400324000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/01/2020
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 Number1
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