MAUDE Adverse Event Report: STRYKER CORPORATION; STRETCHER, WHEELED

Model Number 1501

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

While a patient was transferring from the wheelchair to the exam room stretcher, the stretcher moved back and hit the wall.The stretcher was in the locked/break on position, but still moved about 6 inches which made the patient stumble back and almost fall on the floor.With help from myself and patients' husband she was able to stand up and shuffle back before she hit the floor.

• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 9494765
• MDR Text Key: 171990137
• Report Number: 9494765
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2019
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1