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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED
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STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED Back to Search Results
Catalog Number C1000DF
Device Problem Arcing (2583)
Patient Problem Electric Shock (2554)
Event Date 12/01/2014
Event Type  Injury  
Event Description
It was reported the unit experienced arching and a caregiver was reportedly shocked when the power cord was plugged in.The caregiver was sent to the emergency room and hospitalized for 24 hours for cardiac monitoring.
 
Manufacturer Narrative
Supplemental submitted with results of evaluation.The controller power cord iec connector sheathing at the strain relief section was damaged with exposed metal wires and signs of melting of the insulation.The customer was provided with a replacement controller.
 
Event Description
It was reported the unit experienced arching and a caregiver was reportedly shocked when the power cord was plugged in.The caregiver was sent to the emergency room and hospitalized for 24 hours for cardiac monitoring.
 
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Brand Name
AIR EXPRESS APM
Type of Device
BED, FLOTATION THERAPY, POWERED
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 Key4394838
MDR Text Key5548767
Report Number0001831750-2015-00005
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/10/2014
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? No
Device Operator Other
Device Catalogue NumberC1000DF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2014
Initial Date FDA Received01/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/03/2015
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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