MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE SPO2RT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1900

Device Problems Break (1069); Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Smoke was noticed coming from the red outlet in the patient's room.The bed was unplugged and one of the prongs from the cord is charred, broken off, and hanging out of the outlet.The patient was switched off the bed and taken out of the room.

• Brand Name: TOTALCARE SPO2RT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12582713
• MDR Text Key: 274960421
• Report Number: 12582713
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2021,09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2021
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1