MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for AXIOM MULTIX TOP 475517 manufactured by Siemens Gmbh.
[39424510]
The system was brought back to specifications. The reported issue is under investigation and a supplemental report will be submitted if additional information becomes available. This report was submitted february 24, 2016. Customer's address: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[39424511]
During a routine system maintenance, siemens service team discovered that all m8 screws on the transverse carriage were missing and 3 out of 4 bolts were loose. The unit was immediately brought back to specifications and "safe to use" state. There are no injuries associated with this event. The report event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[54437752]
The investigation of the provided issue showed that the screws were retained with loctite however not completely tightened with torque. Due to the low pre-load of the bolted joints a relative movement (play) between rail and supporting plate exists. This relative movement resulted in another move-behavior of the connection component and led to loosening of the bolted joints. Due to the not strongly tightened bolted joints of the transverse carriage a displacement of the trolley is possible. This is only possible if all screws of the supporting plates are not properly bolted and all locking pins are released off the rail. Therefore the displaced trolley at the transverse carriage could slide off the rail. There was no displacement of the trolley at the concerned customer site. The factory installation team discovered the loose screws during a site visit for a planned service interaction and the issue was addressed internally. A single workmanship error in production was identified as a root cause for the loosened screws. A systematic failure in production can be excluded as systems in the field were checked and no failure could be determined. Furthermore the maintenance records were checked as well and no abnormalities could be identified. For prevention of this issue an additional step was appended in the maintenance instruction. Siemens will continue to systematically check maintenance records.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2016-00698 |
| MDR Report Key | 5457095 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-01-29 |
| Date of Event | 2016-01-27 |
| Date Mfgr Received | 2016-08-17 |
| Date Added to Maude | 2016-02-24 |
| 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 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS GMBH |
| Manufacturer Street | SIEMENSSTRASSE 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 | AXIOM MULTIX TOP |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2016-02-24 |
| Model Number | 475517 |
| 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 GMBH |
| Manufacturer Address | SIEMENSSTRASSE 1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-24 |