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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POSITIONPRO WITH PENDANT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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STRYKER MEDICAL-KALAMAZOO POSITIONPRO WITH PENDANT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Catalog Number 2920100000
Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 05/13/2014
Event Type  Death  
Event Description
It was reported that a patient on the mattress coded and required cpr.While performing cpr, the mattress¿ self-assist turn function was activating on its own due to a pendant malfunction.Conversation with healthcare professionals at the user facility confirmed that the patient coded prior to the malfunction occurring and was not related to the alleged malfunction; that the mattress malfunction did not affect their ability to perform cpr; and further, it was confirmed by the user facility that the cpr handles were not pulled out as is instructed prior to performing cpr.However, the patient could not be resuscitated and subsequently expired.
 
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Brand Name
POSITIONPRO WITH PENDANT
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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 Key3995017
MDR Text Key4779523
Report Number0001831750-2014-03201
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nursing Assistant
Type of Report Initial
Report Date 07/16/2014
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? Yes
Device Operator Other
Device Catalogue Number2920100000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2014
Initial Date FDA Received08/08/2014
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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