MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for MULTIX PRO 5902973 manufactured by Siemens Healthcare Gmbh.
[141913272]
The cause of the incident is assessed as individual workmanship error of the user trying to perform service on the system.
Patient Sequence No: 1, Text Type: N, H10
[141913273]
Siemens became aware of an adverse event with the multix pro system. The user had performed a repair of the patient handgrip and incorrectly placed a snap ring that locks the hand grip in position. The repair work was done without siemens' involvement. The repair was performed incorrectly; however, the user released the unit for regular clinical operation. During an examination, a patient handle that is supposed to be firmly fitted became loose and hit patient's head when she tried to grab it. According to the user, the patient required staples to stitch the wound. No other details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2018-42768 |
| MDR Report Key | 8510799 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-12 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2019-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD, MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSSTR.1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX PRO |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | IZZ |
| Date Received | 2019-04-12 |
| Model Number | 5902973 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |