FDA Adverse Event Malfunction Summary report: N

POLYMOBIL PLUS

MDR report key: 24431360 · Received February 24, 2026

Report

Report Number: 3004977335-2026-00029
Event Type: Malfunction
Date Received: February 24, 2026
Date of Event: February 17, 2026
Report Date: May 28, 2026
Manufacturer: SIEMENS HEALTHINEERS AG
Product Code: IZL
PMA / PMN Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EG
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

E1: THE EVENT WAS REPORTED BY A SIEMENS HEALTHINEERS EMPLOYEE, AND A FACILITY CONTACT NAME AND PHONE NUMBER WERE NOT PROVIDED FOR REPORTING PURPOSES. G4: THIS SYSTEM IS NOT MARKETED AND DISTRIBUTED IN THE USA AND DOES NOT HAVE A 510(K) NUMBER. THIS SYSTEM IS SIMILAR TO THE MOBILETT ELARA MAX, 510(K) K182639. H3, H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): THE CUSTOMER WAS ADVISED TO TAKE THE SYSTEM OUT OF USE IMMEDIATELY. CURRENTLY NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE ROOT CAUSE FOR THE CHAIN BREAK IS UNDER INVESTIGATION. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE SYSTEM. SIEMENS HEALTHINEERS WILL SUBMIT A SUPPLEMENTAL REPORT TO THE FDA AFTER COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 0

ACCORDING TO THE AVAILABLE INFORMATION, ONE OF THE TWO CHAINS WITHIN THE ARM OF THE POLYMOBIL PLUS SYSTEM IS BROKEN. THE RESULTING HIGH TENSION WITHIN THE SYSTEM COULD POSSIBLY LEAD TO BREAKING OF THE SECOND CHAIN AND FALLING OF THE TUBE. THE SAFETY MECHANISM, THE SECOND CHAIN, WORKED IN THIS CASE AND NO DAMAGE TO THIS CHAIN WAS COMMUNICATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
229831	POLYMOBIL PLUS	SYSTEM, X-RAY, MOBILE	IZL	SIEMENS HEALTHINEERS AG	10187800

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown