MAUDE Adverse Event Report: HILL-ROM, INC. HOSPITAL SIGNALING AND NURSE CALL EQUIPMENT PILLOW SPEAKER; SYSTEM, COMMUNICATION, POWERED

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/23/2021

Event Type  Injury  

Event Description

Patient sustained a skin boil/burn from hill-rom call light pillow speaker device.The device overheated and the patient noticed a burn on his forearm when he woke up.Fda safety report id# (b)(4).

• Brand Name: HOSPITAL SIGNALING AND NURSE CALL EQUIPMENT PILLOW SPEAKER
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 12377218
• MDR Text Key: 268731880
• Report Number: MW5103530
• Device Sequence Number: 1
• Product Code: ILQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR