MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2004-12-02 for QUANTIX/OR 4210 CSN 00210 manufactured by Cardiosonix, Ltd..
[312932]
Distributor's rep reported that following cleaning and soaking as described in the product's user manual, the probe was leaking fluid from under the cover sheet of the probe handle; approximately 20-30 drops.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003596523-2004-00001 |
| MDR Report Key | 558348 |
| Report Source | 01,07,08 |
| Date Received | 2004-12-02 |
| Date of Event | 2004-11-29 |
| Date Facility Aware | 2004-11-29 |
| Date Reported to Mfgr | 2004-11-29 |
| Date Mfgr Received | 2004-11-29 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2004-12-09 |
| 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 | 3 |
| Manufacturer Street | 425 METRO PLACE NORTH #300 |
| Manufacturer City | DUBLIN OH 430171367 |
| Manufacturer Country | US |
| Manufacturer Postal | 430171367 |
| Manufacturer Phone | 6148222342 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTIX/OR |
| Generic Name | BLOOD FLOWMETER |
| Product Code | DPW |
| Date Received | 2004-12-02 |
| Model Number | 4210 |
| Catalog Number | CSN 00210 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 548020 |
| Manufacturer | CARDIOSONIX, LTD. |
| Manufacturer Address | 8 HASADNA ST RA'ANANA IS 43654 |
| Baseline Brand Name | QUANTIX/OR |
| Baseline Generic Name | BLOOD FLOWMETER |
| Baseline Model No | 4210 |
| Baseline Catalog No | CSN 00210 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-02 |