MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-07-13 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[20756831]
Customer restored failed automatic quality control (aqc) parameter (pco2) and run patient samples on the instrument. Customer indicated that there were 2 patients run between 8am and 4pm on (b)(6) 2015. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[21033002]
Customer should not have restored failed aqc parameter (po2) and run patient sample. Customer confirmed that patients' treatment and health were not affected by this event. Customer indicated that they would re-train their operators on the proper way to re-run failed aqc. The event has occurred due to an operator error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00097 |
| MDR Report Key | 4908995 |
| Report Source | 06,07 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-13 |
| Date Mfgr Received | 2015-06-16 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-07-13 |
| Catalog Number | 10322347 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-13 |