MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SM204 M-SERIES W/BIG WHEEL; STRETCHER, WHEELED

Catalog Number 1015000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

It is alleged that a patient fell between an m-series big wheel and an operating room table.It is reported that the patient had a ct scan and medical intervention following the alleged fall.

Manufacturer Narrative

The event occurred as they were transferring a patient from the or table to the m-series stretcher.It was reported that a 4 person transfer was in use with a person on each side of the stretcher as well as the foot end and head end.When the patient was mid transfer the brakes of the stretcher disengaged, resulting in the patient falling between the stretcher and the table.The patient hit their head during the fall and a ct scan was performed as a precaution.The ct scan came back clear, however the patient suffered bruising as a result of the event.The injury was treated with an ice pack.An attempt to evaluate the unit was made, however upon contacting the hospital it was reported that the unit had been removed from use.Device not available.

Event Description

It is alleged that a patient fell between an m-series big wheel and an or table.

• Brand Name: SM204 M-SERIES W/BIG WHEEL
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8460789
• MDR Text Key: 140204581
• Report Number: 0001831750-2019-00287
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1015000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1