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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO XT; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO POWER-PRO XT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6506000000
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.24 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 24 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
 
Manufacturer Narrative
An additional event was identified and therefore added to this summary report.
 
Event Description
This report summarizes 25 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
 
Manufacturer Narrative
Initially it was reported that there were 2 instances of this hazard/model number combination.Further review of records identified that one record was a duplicate.The number of occurrences summarized have been updated to reflect this.
 
Event Description
This report summarizes 24 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
 
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Brand Name
POWER-PRO XT
Type of Device
STRETCHER, WHEELED
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
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19159614
MDR Text Key341387831
Report Number0001831750-2024-00566
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261639
UDI-Public07613327261639
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported24
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 07/11/2024
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 Catalogue Number6506000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/22/2024
Supplement Dates Manufacturer Received04/01/2024
04/01/2024
Supplement Dates FDA Received04/29/2024
07/11/2024
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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