MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6506 MTS PWRPRO COT LOW CONFIG; STRETCHER, WHEELED

Model Number	6506
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while loading a patient into the ambulance, the cot did not raise high enough causing the cot to slip off the back of the ambulance and tip over with the patient.The patient reportedly sustained a head laceration which was treated with stitches in the local er.The patient also reported that the fall aggravated an existing eye injury, however, no treatment information was available for that injury.

• Brand Name: 6506 MTS PWRPRO COT LOW CONFIG
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13015144
• Report Number: 0001831750-2021-01650
• Device Sequence Number: 17380695
• Product Code: FPO
• UDI-Device Identifier: 07613327513288
• UDI-Public: 07613327513288
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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 Model Number: 6506
• Device Catalogue Number: 650605550001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown