MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT XP HYBRID; MOBILE X-RAY SYSTEM

Model Number 01818454

Device Problem Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The system was checked by siemens local service.The engineer noticed that one screw was loose.The engineer re-attached the screw and tightened the peripheral screws.The system was brought back to specifications.Customers address: (b)(6).

Event Description

It was reported that during a surgery while using the mobilett xp hybrid system, a washer fell down.The washer hit the patient; however, it did not comprise the operation area.There are no injuries related to this incident.The reported event occurred in (b)(6).

• Brand Name: MOBILETT XP HYBRID
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8540824
• MDR Text Key: 142794734
• Report Number: 3002808157-2017-02060
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K827929
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01818454
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other