MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1996-11-07 for ABG MODULE manufactured by Marquette Electronics.
[21591288]
A distributor reported that one analyzer was found to have its optical filters interchanged. This was found during their incoming inspection. Investigation of this incident determined that the order of these filters, if interchanged could affect the accuracy of pt readings. A process has been implemented in mfg to insure each parameter is paired with its corresponding optical filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-1996-00023 |
| MDR Report Key | 49429 |
| Report Source | 08 |
| Date Received | 1996-11-07 |
| Date of Report | 1996-10-15 |
| Date of Event | 1996-10-15 |
| Date Facility Aware | 1996-10-15 |
| Report Date | 1996-10-15 |
| Date Mfgr Received | 1996-10-15 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1996-11-19 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABG MODULE |
| Generic Name | ARTERIAL BLOOD GAS ANALYZER |
| Product Code | CCC |
| Date Received | 1996-11-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 50172 |
| Manufacturer | MARQUETTE ELECTRONICS |
| Manufacturer Address | 8200 W. TOWER AVE. MILWAUKEE WI 53223 US |
| Baseline Brand Name | ABG MODULE |
| Baseline Generic Name | ARTERIAL BLOOD GAS ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | ABG |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951094 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-07 |