MAUDE Adverse Event Report: MAC SURGICAL (BELIMED) / BELIMED AG DECONTAMINATION SINK; DISINFECTOR, MEDICAL DEVICES

Model Number PS9637A3AH-37B1-37C3-37D9

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Belimed (mac surgical) decontamination sink has been broken and out of service for several weeks.The repair person was here on several occasions to fix this equipment without resolve.This issue was elevated with belimed but still remains without resolve.Fda safety report id # (b)(4).

• Brand Name: DECONTAMINATION SINK
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): MAC SURGICAL (BELIMED) / BELIMED AG
• MDR Report Key: 13252175
• MDR Text Key: 283955388
• Report Number: MW5106639
• Device Sequence Number: 1
• Product Code: MEC
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS9637A3AH-37B1-37C3-37D9
• Device Catalogue Number: PS9637A3AH-37B1-37C3-37D9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1