MAUDE Adverse Event Report: DORNIER GENESIS / DORNIER MEDTECH SYSTEMS GMBH DMT CYSTO TABLE; TABLE, CYSTOMETRIC, NON-ELECTRIC AND ACCESSORIES

Lot Number S/N 0039

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

X-ray on cysto table would not function.Motor drive failed.Fda safety report id# (b)(4).

• Brand Name: DMT CYSTO TABLE
• Type of Device: TABLE, CYSTOMETRIC, NON-ELECTRIC AND ACCESSORIES
• Manufacturer (Section D): DORNIER GENESIS / DORNIER MEDTECH SYSTEMS GMBH
• MDR Report Key: 10326204
• MDR Text Key: 200809060
• Report Number: MW5095725
• Device Sequence Number: 1
• Product Code: KQS
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: S/N 0039
• Was Device Available for Evaluation?: 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: 55 YR