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 2020-03-17 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10492730 manufactured by Siemens Healthcare Diagnostics.
[183973660]
This issue has been escalated to software engineering for evaluation. The trace log provided by the customer had the incorrect time frame. Siemens has requested the trace log with the correct time frame. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[183973661]
The customer reported they ran a patient on the rp 500 and the user confirms the patient id was scanned correctly, all results on the patient's chart are correct, the printouts from the analyzer are correct and the rapidcomm results are correct. When the user recalled the patient list, several results from the previous 24 hours were all overwritten with one, different patient id. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00012 |
| MDR Report Key | 9844902 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7052212 |
| 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 500 BLOOD GAS ANALYZER |
| Generic Name | RP 500 |
| Product Code | CHL |
| Date Received | 2020-03-17 |
| Model Number | 10492730 |
| Catalog Number | 10492730 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |