• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER30INLITTER; STRETCHER, WHEELED, POWERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER30INLITTER; STRETCHER, WHEELED, POWERED Back to Search Results
Catalog Number 1125000030
Device Problem Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 2 units had broken/damaged components and 2 had worn components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the zoom function had unintended motion.There was no patient involvement.
 
Manufacturer Narrative
Supplemental submitted to include gtin.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the zoom function had unintended motion.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIME ZOOM STRETCHER30INLITTER
Type of Device
STRETCHER, WHEELED, 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 Key8556988
MDR Text Key143713078
Report Number0001831750-2019-00472
Device Sequence Number1
Product Code INK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1125000030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2019
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
-
-