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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POWER PACK, EXTENDED LIFE; HELMET, SURGICAL

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STRYKER INSTRUMENTS-KALAMAZOO POWER PACK, EXTENDED LIFE; HELMET, SURGICAL Back to Search Results
Catalog Number 0408660000
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
Event Type  malfunction  
Event Description
The sales representative observed that the device heated up during testing at the user facility.There were no reported adverse consequences.
 
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Brand Name
POWER PACK, EXTENDED LIFE
Type of Device
HELMET, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7630108
MDR Text Key112050378
Report Number0001811755-2018-01084
Device Sequence Number1
Product Code FXZ
UDI-Device Identifier04546540591654
UDI-Public04546540591654
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2018
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 Number0408660000
Device Lot Number20180302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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