MAUDE Adverse Event Report: DORNIER MEDTECH SYSTEM GMBH DORNIER RELAX + TABLE; RELAX+ TABLE

Model Number K1018869

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  Injury  

Event Description

The relax+table paired with the compact delta lithotripter (b)(4) started going up and wouldn't stop while a patient was on the table.Possible patient injury was reported.The patient was sent for an x-ray and examined at the hospital that day and subsequently released.Two weeks after the incident the patient was contacted by the hospital and reported no injury.

Manufacturer Narrative

Based on the evaluation and analysis of the suspect relax-band hand controller component, the following can be concluded: the failure of the hand controller was likely not due to any inherent design flaw.This is a very rare occurrence whose specific cause could not be determined.This customer is not under a dornier service contract.Therefore, dornier does not know the service capabilities or qualifications of the 3rd party that services the device, nor the service/maintenance history of this device.We believe the cause could be related to lack of proper inspection and maintenance at appropriate frequency by the 3rd party service contractor.There is no trend of this failure mode in the field on any units.(b)(4).

• Brand Name: DORNIER RELAX + TABLE
• Type of Device: RELAX+ TABLE
• Manufacturer (Section D): DORNIER MEDTECH SYSTEM GMBH; wessling, bavaria ; GM
• Manufacturer Contact: heather jenkins ; 1155 roberts blvd.; kennesaw, GA 30144 ; 7705146123
• MDR Report Key: 4917729
• MDR Text Key: 6055053
• Report Number: 1037955-2015-00014
• Device Sequence Number: 1
• Product Code: LNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K1018869
• Device Catalogue Number: K1018869
• Other Device ID Number: 112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2015
• Distributor Facility Aware Date: 06/17/2015
• Device Age: 10 YR
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other