MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-03-13 for ABL700SERIES AND ABL800SERIES * manufactured by Radiometer Medical Aps.
[469710]
The description is according to standard for medical devices- coding structure for adverse event type and cause iso/ts 19218. See ae cause term 540 and 950. 540 calibration error. Inaccurate results with medical measurement devices (e. G. For temperature, mass, ph, ivd test results) due to incorrect calibration. 950 user error. An act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator causing a device failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00018 |
| MDR Report Key | 687353 |
| Report Source | 01,06 |
| Date Received | 2006-03-13 |
| Date of Report | 2006-03-06 |
| Date of Event | 2006-02-09 |
| Date Mfgr Received | 2006-02-09 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-03-17 |
| 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 | 0 |
| Manufacturer Contact | LISE-LOTTE RINGBY |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL700SERIES AND ABL800SERIES |
| Generic Name | BLOODGAS ANALYZER |
| Product Code | CCE |
| Date Received | 2006-03-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 754R0052N004 |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676562 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-13 |