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

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

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 09/13/2017

Event Type  Injury  

Event Description

(b)(4) healthcare received the included information.The device(s) in question was not manufactured nor imported by (b)(4) healthcare, per section 803.22 (8) (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 (b)(4) on september 29, 2017.Over the weekend (09/16),per anna/rn (night charge nurse) approached fst and wanted to report an incident with our equipment where a pt had fallen from the bed and landed on the floor.The pt slid down onto the floor between the opening of the side rails.She said the (2) side pull out rakis were not extended and the mattress collapsed where there was no support.An injury listed, injured with a dislocated shoulder complained.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17533642
• MDR Text Key: 321151629
• Report Number: MW5140546
• 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: 09/29/2017

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
• Patient Sequence Number: 1
• Patient Age: 82 YR