MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-31 for CARDIO LAB CARDIO LAB II PLUS * manufactured by General Electric.
[409844]
Pt had decreased bp - art line inserted for continuous pressure monitoring. Transducer zeroed; nibp corrected with arterial pressure. Unable to monitor nibp arterial pressure continuously due to limitation of system, so arterial pressure monitored e. Logged. Nibp correlated with arterial pressure prior to arterial sheath removal. When sheath removed, transducer disconnected form pressure cable - mathematically correct number displayed under pressure (i. E. 127/60/83). Numbers cont'd to change as if pressure was still being monitored. Pressure cable disconnected from amplifier - system cont'd to display pressure numbers. Questioning reliability of invasive pressure monitoring - treating an inaccurate pressure could lead to pt harm. This is a recurrent problem that had been addressed with ge in nov. '04.
Patient Sequence No: 1, Text Type: D, B5
[470551]
Add'l info rec'd from mfr 1/13/06: the operation reported by the customer is according to design specifications and product labeling. The customer reported the invasive blood pressure cable was disconnected from the amplifier input, indicating the customer awareness of this action. The customer further reported that the observed values in the blood pressure parameter window were confusing. The mac-lab and cardiolab system operators manuals caution users to not display channels which have unused catheter input modules. Testing verified the reported complaint. The operators manuals caution users about and provide instructions on how to avoid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035079 |
| MDR Report Key | 588442 |
| Date Received | 2005-03-31 |
| Date of Report | 2005-03-24 |
| Date of Event | 2005-03-22 |
| Date Added to Maude | 2005-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIO LAB |
| Generic Name | ELECTROPHYSIOLOGY LAB |
| Product Code | DRR |
| Date Received | 2005-03-31 |
| Model Number | CARDIO LAB II PLUS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 578293 |
| Manufacturer | GENERAL ELECTRIC |
| Manufacturer Address | * MILWAUKEE WI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-31 |