MAUDE Adverse Event Report: STABER INDUSTRIES, INC. STABER DRYER; UNIT, DRYING

Model Number IDC2201

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

Staber dryer used in cme area of hospital malfunctioned resulting in melting of parts and smoke in department.Preliminary investigation indicates that safety mechanism for over heating failed.Allowing the dryer to become too hot.Fda safety report id # (b)(4).

• Brand Name: STABER DRYER
• Type of Device: UNIT, DRYING
• Manufacturer (Section D): STABER INDUSTRIES, INC. ; 4800 homer ohio lane; groveport OH 43125
• MDR Report Key: 11552373
• MDR Text Key: 241956118
• Report Number: MW5100162
• Device Sequence Number: 1
• Product Code: JRJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: IDC2201
• Device Catalogue Number: SERIES-W)1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1