MAUDE Adverse Event Report: BERCHTOLD GMBH AND CO. KG BERCHTOLD; OPERON B 710 SURGICAL BED

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Berchtold operon b 710 surgical bed in use.Bed was raised and patient positioned, tried to raise bed higher at start of surgeon portion of surgery, would respond with action, burning smell noted, circuit board with burn area noted near connections.No fire broke out, no smoke noted but black burn area noted on circuit board.No harm to patient, patient was awakened from surgery prior to start until source of melting smell noted, then was put back under general anesthesia for surgery to be completed.

• Brand Name: BERCHTOLD
• Type of Device: OPERON B 710 SURGICAL BED
• Manufacturer (Section D): BERCHTOLD GMBH AND CO. KG
• MDR Report Key: 7464066
• MDR Text Key: 106792414
• Report Number: MW5076745
• Device Sequence Number: 0
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Age: 38 YR
• Patient Weight: 90