MAUDE Adverse Event Report: STRETCHER; STRETCHER, WHEELED

Model Number P800

Device Problem Mechanical Problem (1384)

Patient Problems Hearing Impairment (1881); Muscle Weakness (1967); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2019

Event Type  malfunction  

Event Description

Patient went to mri department for imaging due to symptoms of stroke: asphasia, new onset hard of hearing, and leg weakness rendering it hard for him to stand.In preparing to move patient from stretcher to table, it was noticed that the stretcher was not locking securely.The tech was trying to hold both stretcher and table at the same time.The patient was instructed to move over.He slid once/twice over between both stretcher and table and started flipping several times.He was found lying on his right hip and side.

• Brand Name: STRETCHER
• Type of Device: STRETCHER, WHEELED
• MDR Report Key: 16815392
• MDR Text Key: 314014104
• Report Number: 16815392
• 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: 04/19/2023,08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P800
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: Black Or African American