MAUDE Adverse Event Report: CAREMED MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number RC 1000UB

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

Patient Problem Fall (1848)

Event Date 02/21/2017

Event Type  Injury  

Event Description

Joerns healthcare received the included information.The device(s) in question was not manufactured nor imported by joerns 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 joerns on march 10, 2017.Per (b)(6) called customer service for a different frame and air surface,due to the patient moving, and rolling out of the bed,wade said no injury to patient, the patient rolled out of the bed on the night of (b)(6) 2017,and the order was placed the evening of (b)(6) 2017,the equipment was picked up, and quarantined pending any investigation,and we del a new frame, and a bari rise1000 matt withe side bolsters inflated,facility was satisfy with the new equipment.No injuries listed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17535711
• MDR Text Key: 321149598
• Report Number: MW5142606
• Device Sequence Number: 1
• Product Code: FNM
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: RC 1000UB
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1