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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE.
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STRYKER INSTRUMENTS-KALAMAZOO AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE. Back to Search Results
Catalog Number 0206500000
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2015
Event Type  malfunction  
Event Description
The customer reported that during a procedure the automatic foot pump had issues holding pressure.As a result of the event, the procedure was delayed by 30 minutes.There were no adverse consequences or medical intervention.
 
Manufacturer Narrative
Device not returned.
 
Event Description
The customer reported that during a procedure the automatic foot pump had issues holding pressure.As a result of the event, the procedure was delayed by 30 minutes.There were no adverse consequences or medical intervention.
 
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Brand Name
AUTOMATIC HIGH VACUUM FOOT PUMP
Type of Device
MIXER, CEMENT, FOR CLINICAL USE.
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5034337
MDR Text Key24210783
Report Number0001811755-2015-03136
Device Sequence Number1
Product Code JDZ
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 user facility
Reporter Occupation Other
Type of Report Followup
Report Date 07/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0206500000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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