MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX; STATIONARY X-RAY SYSTEM

Model Number 10762473

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on (b)(6) 2019.Additional information was requested by factory experts.Investigation is on-going.A supplemental report will submitted if additional information becomes available.

Event Description

Siemens was informed by its service organization about an incident when the monitor suspension on the uroskop omnia max detached from the support arm.The monitor suspension was caught by the monitor cable, thus, preventing the fall.There are no injuries attributed to this event.The reported event occurred in (b)(6).

• Brand Name: UROSKOP OMNIA MAX
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8531623
• MDR Text Key: 142800518
• Report Number: 3004977335-2018-59618
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2018

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: 10762473
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2018
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other