MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2005-04-15 for BLOOD GAS ANALYZER ABL725 * manufactured by Radiometer Medical Aps.
[20138744]
During a gas calibration of the radiometer model abl725 blood gas analyzer it reported an error (drift) on pc02. The user checked the analyzer and discovered a clot under the pc-2 electrode that was removed. The user had set-up the analyzer such that any calibration errors should result in flagged measurements. Performing standard blood gas measurements the physician noticed that the pc02 values reported were much higher than expected, but they were not flagged even that the analyzer again had failed its gas calibration. Repeated measurements were subsequently made on the same analyzer and on a back-up analyzer. The malfunctioning analyzer reported values that were 20 - 30 mmhg higher than the values on the back-up analyzer that were within the expected values. The pt was on wrong ventilator settings for approximately 15 minutes before the error was discovered and settings reverted to the correct ones. No illnesses or injuries have been reported as occurring as a result of the circumstances described above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2005-00003 |
| MDR Report Key | 594888 |
| Report Source | 05,06,08 |
| Date Received | 2005-04-15 |
| Date of Report | 2005-04-15 |
| Date of Event | 2005-03-17 |
| Date Mfgr Received | 2005-03-17 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2005-04-26 |
| 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 | LEIF GUDNITZ |
| Manufacturer Street | AKANDEVEJ 21, |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| 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 | BLOOD GAS ANALYZER |
| Generic Name | ABL 700 AND ABL800 SERIES ANALYZERS |
| Product Code | CCE |
| Date Received | 2005-04-15 |
| Model Number | ABL725 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 584719 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | ABL725 |
| Baseline Generic Name | IN VITRO DIAGNOSTIC DEVICE, BLOOD GAS ANALYZER |
| Baseline Model No | ABL725 |
| Baseline Catalog No | UNK |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-04-15 |