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 |