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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 8001-061-610
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that while preparing for a case the blanket popped, and leaked water on to the patient support area.There was no patient involved at the time of this event.
 
Additional Manufacturer Narrative
Adverse event or product problem was originally reported as an adverse event in error.Section b1 has been updated to reflect that this event was a product problem only and did not result in any adverse consequences.
 
Event or Problem Description
It was reported that while preparing for a case the blanket popped and leaked water on to the patient support area.There was no patient involved at the time of this event.
 
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Brand Name
BLKT 1-SIDE NONWOV COLDER CON
Common Device Name
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10658059
Report Number0001831750-2020-00928
Device Sequence Number3004130
Product Code DWJ
UDI-Device Identifier07613327175127
UDI-Public07613327175127
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K152266
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8001-061-610
Device Catalogue Number8001061610
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/15/2019
Supplement Date Received by Manufacturer07/15/2019
Initial Report FDA Received Date10/09/2020
Supplement Report FDA Received Date11/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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