MAUDE Adverse Event Report: TRIDIEN MEDICAL; HILL-ROM, INC. 1. THERAFLO M-SET 36'' ? 80'' QLT RECOVER; BED, FLOTATION THERAPY, POWERED

Model Number 1. STAT 5000C. 2. CU (CR317)

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

Patient Problem Fall (1848)

Event Date 06/09/2021

Event Type  Injury  

Event Description

(b)(6) called in from (b)(6) to ask us to pick up patients equipment due to her receiving a report of the patient falling.She did not have many details other than the mattress was delivered sometime saturday and they reported that the patient fell to her this morning.Per (b)(6) as far as she knows the patient did not sustain any injuries and did not have to be seen by a ppysician.I asked if they wanted a replacement and she stated that at this time she was just being asked to have the equipment picked up.This patient was on an ra3000 which assets were r166091 and r504025.The mattress is still at the facility awaiting pick up in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1. THERAFLO M-SET 36'' ? 80'' QLT RECOVER
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): TRIDIEN MEDICAL; HILL-ROM, INC.
• MDR Report Key: 17524456
• MDR Text Key: 321136027
• Report Number: MW5131403
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 07/09/2021

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: 1. STAT 5000C. 2. CU (CR317)
• Device Catalogue Number: 3001020, 2001013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: FNL