MAUDE Adverse Event Report: CAREMED BED, AC-POWERED ADJUSTABLE HOSPTIAL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number ULTRACAIR, FM-PCS0011

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

Patient Problem Fall (1848)

Event Date 05/27/2017

Event Type  Injury  

Event Description

(b)(4) received the included information.The device(s) in question was not manufactured nor imported by joerns healthcare, per section 803.22 (b) (2) we are submitting the following information.We are forwarding this information for further evaluation and processing.The manufacturer, caremed, of the device involved in the attached incident was notified by joerns on june 5, 2017.Patient fell out of mattress and as a result is in the hospital.Injuries listed, injuries are unknown.Per arthur, patient was placed in the hospital per the fall from mattress.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPTIAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17534736
• MDR Text Key: 321163308
• Report Number: MW5141636
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ULTRACAIR, FM-PCS0011
• Patient Sequence Number: 1