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

Model Number ULTRACAIR, FM-PCS0014 V1

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

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Joerns healthcare received the included information.The device(s) in question was not manufactured nor imported by (b)(6) , 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 (b)(6) on august 28, 2017.(b)(6) stated that the patient has fallen multiple times (about 4) off the mattress; she said the bed did not work for the pt and that there were no injuries.Any further information please contact her cell phone (b)(6).The item will be located for maintenance storage for the pickup, let the nurses know and they will direct the technician.Pu scheduled under (b)(4).Ni 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: 17531715
• MDR Text Key: 321130956
• Report Number: MW5138628
• 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: 08/28/2017

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-PCS0014 V1
• Patient Sequence Number: 1