MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-04-23 for ADVIA CENTAUR XP 078-A010-04 manufactured by Siemens Healthcare Diagnostics, Inc..
[5748097]
The cover of an advia centaur xp instrument fell onto an operator, hitting their head. The incident caused the operator to have a small mark on their head. No medical intervention or treatment was required.
Patient Sequence No: 1, Text Type: D, B5
[13170601]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced the gas spring for the instrument cover and verified the instrument is operational. The cause of the instrument cover falling onto an operator was a malfunction of the gas spring. This instrument is performing according to specifications. No further evaluation of this device is required. Siemens healthcare diagnostics has investigated the occurrences of advia centaur xp instrument covers falling during maintenance procedures. When the instrument cover is raised, the cover is supported by a gas spring attached at the middle of the cover. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling during maintenance procedures. Customers in the united states were sent urgent medical device correction (umdc) 10817522 entitled "advia centaur xp instrument cover gas spring issues" in february 2014. Customers outside of the united states were sent urgent field safety notice (ufsn) 10817521 entitled "advia centaur xp instrument cover gas spring issues" in february 2014. The umdc/ufsn provides guidance to customers by explaining actions to avoid injury and to contact their siemens technical support representative if the cover cannot stay partially raised. Siemens technical support representatives will be routinely inspecting gas springs on regular preventive maintenance cycles or service visits.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00210 |
| MDR Report Key | 4724490 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-04-23 |
| Date of Report | 2017-12-12 |
| Date of Event | 2015-04-14 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2007-09-03 |
| Date Added to Maude | 2015-05-26 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | DUBLIN, SWORDS |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-02/21/14-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-04-23 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-23 |