MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Model Number	6100
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the devices experienced unintended cot lowering or cot dropping to lowest position.There were 3 events with patient involvement; no adverse consequences were reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found.
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the devices experienced unintended cot lowering or cot dropping to lowest position.There were 3 events with patient involvement; no adverse consequences were reported.
Event or Problem Description
This report summarizes 3 malfunction events, where it was reported the devices experienced unintended cot lowering or cot dropping to lowest position.There were 2 events with patient involvement; no adverse consequences were reported.
Additional Manufacturer Narrative
The device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Section h codes have been updated.Because of this, the number of reported events has been changed from 4 to 3.2 devices are still pending evaluation.
Additional Manufacturer Narrative
One device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Section h codes have been updated.Because of this, the number of reported events has been changed from 3 to 2.1 device is still pending evaluation.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced unintended cot lowering or cot dropping to lowest position.There were 2 events with patient involvement; no adverse consequences were reported.
Additional Manufacturer Narrative
The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced unintended cot lowering or cot dropping to lowest position.There were 2 events with patient involvement; no adverse consequences were reported.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• Common Device Name: 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 Key: 16819484
• Report Number: 0001831750-2023-00626
• Device Sequence Number: 1804728
• Product Code: FPO
• UDI-Device Identifier: 07613327261530
• UDI-Public: 07613327261530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/12/2023

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 Model Number: 6100
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2023
• Supplement Date Received by Manufacturer: 04/01/2023; 04/01/2023; 04/01/2023; 04/01/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/12/2023; 07/24/2023; 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown