MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SIREMOBIL COMPACT L; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 3780629

Device Problems Output Problem (3005); Unexpected/Unintended Radiation Output (4028)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).

Event Description

It was reported to siemens that a malfunction occurred while operating the siremobil compact l system.The unit was randomly taking fluoro images without any personnel pressing buttons or pushing pedals.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in canada.

Manufacturer Narrative

Siemens conducted a detailed investigation of the reported event.The investigation was performed on expert discussions (considering complaint description, customer service (cs) reports, and system history).According to the information provided by the user, unexpected fluoro images were taken by the system itself without pushing the exposure button of hand or footswitch.The customer recognized fluoroscopy in progress by an active radiation sign (lamp) and the x-ray image on the monitor.Since the customer's in-house technician did not determine a failure, siemens service was called to troubleshoot the problem.During the on-site service intervention, a displaced spring of the foot switch was found.This causes the foot pedal to require less force to be actuated.However, this cannot explain the effect described, as pressure still must be applied to the pedal to actuate the switch and trigger x-ray.No defect was found resulting in the erroneous behavior.The situation could not be reproduced/simulated.As a preventive measure, since the spring was displaced, the foot switch was replaced as part of the service.Since no further information could be provided and the failure did not recur, additional investigation was not performed.The problem reported by the customer could not be confirmed.The error mentioned in the complaint has not again been reported since then.The occurrence rate of the aforementioned error pattern was checked.There are no reports of similar cases.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described was not classified as a reportable adverse event.After the detailed investigation, neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected, even if the event recurs.H11 corrected data: b2: other serious or important medical events should not have been check in the initial report submitted on august 31, 2022.This issue did not result in an adverse event.G2: the initial report source was health professional.User facility was checked in error.

• Brand Name: SIREMOBIL COMPACT L
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15327208
• MDR Text Key: 299009042
• Report Number: 3004977335-2022-40197
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K963093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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: 3780629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other