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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER CORPORATION; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number STRYKER CRIB
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2019
Event Type  malfunction  
Event Description
Our fleet of bed cribs have plexi-glass inserts.The inserts have developed cracks that could potentially harm an infant.The hospital reached out to the vendor for options and was informed the cribs are end of life and end of service, no parts available.The hospital has not received any notification of the eol or eos dates.The cribs are approximately 6 years old.Manufacturer response for infant crib, (brand not provided) (per site reporter).The manufacturer informed the hospital the damage was part of the normal wear and tear.However, they also informed us the device was at end of life and end of service.Since they are at eol/eol, the mfg is recommending purchasing new models.The concern is there was never any notification to the hospital of this eol/eos dates.
 
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Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
STRYKER CORPORATION
2825 airview blvd
portage MI 49002
MDR Report Key9284412
MDR Text Key165234124
Report Number9284412
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/20/2019
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 Health Professional
Device Model NumberSTRYKER CRIB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2019
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer11/06/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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