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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BASSINET, MODERN STYLE; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO BASSINET, MODERN STYLE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number 4400124000
Device Problems Break (1069); Detachment Of Device Component (1104); Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2015
Event Type  malfunction  
Event Description
It was reported via repair work order that a caster was broken off the bassinet, causing the unit to be unstable.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported via repair work order that a caster was broken off the bassinet, causing the unit to be unstable.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The unit could not be repaired so a replacement bassinet was provided to the customer.
 
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Brand Name
BASSINET, MODERN STYLE
Type of Device
BED, PEDIATRIC OPEN 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 Key4621135
MDR Text Key5576237
Report Number0001831750-2015-00128
Device Sequence Number1
Product Code FMS
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 02/19/2015
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 Other
Device Catalogue Number4400124000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2015
Initial Date FDA Received03/20/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/27/2015
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 Number1
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