MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-11-05 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[30573912]
A customer bulletin had been made available to address customers disabling the automatic qc setting on blood gas instruments and failing to reselect and save the aqc option in the setup. Customer has been provided with the bulletin. The event has occurred due to an operator error. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[30573913]
Customer reported that they did not run automatic quality control (aqc) from (b)(6) 2015 through (b)(6) 2015. Customer indicated that patient samples were being run during this period of time. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2015-00155 |
| MDR Report Key | 5205253 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-11-05 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-11-05 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2015-11-05 |
| Catalog Number | 10322347 |
| Device Availability | * |
| 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 | 2015-11-05 |