MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for RAPIDPOINT 500 10492730 manufactured by Siemens Healthcare Diagnostics.
[40427841]
Customer assisted by another co-worker edited rapidcomm patient database to resolve the issue. Customer does not want to be contacted further concerning this issue.
Patient Sequence No: 1, Text Type: N, H10
[40427842]
Customer reported that incorrect patient demographics was populated when they scanned barcode accession number on (b)(4). Customer confirmed that no incorrect results were reported. There was no delay in patient reporting impacting medication procedure, treatment or interventions for a patient and/or to protect public health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00028 |
| MDR Report Key | 5495702 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-02-23 |
| Date Added to Maude | 2016-03-11 |
| 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 500 |
| Generic Name | RP 500 |
| Product Code | GKR |
| Date Received | 2016-03-11 |
| Catalog Number | 10492730 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2016-03-11 |