• 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 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

  • 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 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED Back to Search Results
Catalog Number 650705550001
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2023
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.13 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 14 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler - cannot be lowered.There was no patient involvement.
 
Manufacturer Narrative
The device that was pending was evaluated and it was determined the device experienced cot difficult to raise/lower, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 14 to 13.
 
Event Description
This report summarizes 13 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler - cannot be lowered.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
6507 POWER PRO 2, HIGH CONFIG
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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key17378547
MDR Text Key319581886
Report Number0001831750-2023-00921
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported13
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/19/2023
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 Number650705550001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/01/2023
Initial Date FDA Received07/24/2023
Supplement Dates Manufacturer Received07/01/2023
Supplement Dates FDA Received09/19/2023
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
-
-