MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-04 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[24779547]
Customer should not have run patient sample when qc out of range for po2. Customer checked the three patients that were run during this time and found that comparable are about equivalent on all with close oxygen%. Customer gave example of one patient po2 drawn at 13:02 with result of 84. 5 and drawn again at 15:10: po2 83. 7. Customer confirmed that there were no adverse impacts to patient treatments. Siemens customer care center representative discussed security settings with customer. The event has occurred due to an operator error.
Patient Sequence No: 1, Text Type: N, H10
[24779588]
Customer reported that they run 3 patient samples when quality control (qc) was out of range for po2. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2015-00115 |
| MDR Report Key | 4965774 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-08 |
| Date Mfgr Received | 2015-07-09 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-08-04 |
| Catalog Number | 10322347 |
| Device Availability | I |
| 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 | 2015-08-04 |