MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-03 for RAPID 1265 RL1265 manufactured by Siemens Healthcare Diagnostics.
[21750506]
Customer reports a hemoglobin result reported on a pt in the icu was incorrect. The pt rec? D blood transfusions based on the test result.
Patient Sequence No: 1, Text Type: D, B5
[21905342]
Customer reported that the problem was probably caused by a clot in the co-oximeter. Customer has also questioned whether results are being transmitted correctly via rapidcomm info software. Customer is sending trace logs for review by mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00076 |
| MDR Report Key | 2913614 |
| Report Source | 07 |
| Date Received | 2013-01-03 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-12-03 |
| Date Mfgr Received | 2012-12-03 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2013-02-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, SUFFOLK |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID 1265 |
| Generic Name | RAPID 1265 |
| Product Code | GIG |
| Date Received | 2013-01-03 |
| Model Number | RL1265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-03 |