MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2006-04-27 for DC-II COLLINS FILTER K022454 manufactured by Ferraris Respiratory Inc.
[3454200]
Event description as reported by user through medwatch program: during diffusion test, pt inhaled fast and deep and started to cough uncontrollably. Pt coughed up a small (approximately 3/4" x 1/2 cm) piece of plastic which came from the inside of the pt filter on the mouthpiece. Pulmonary function test continued with different mouthpiece and filter. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[10739891]
Suspect that plastic described by user is from a damaged filter support fin the broke from one of the plastic halves. First report of such issue. Have reviewed filter assembly work instructions that note that inspection of components is to take place prior to the sonic welding step. Will edit the instructions with pictures to identify specific issues/areas to be inspected and unacceptable conditions to be looking for.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722076-2006-00001 |
| MDR Report Key | 3131333 |
| Report Source | 00,05,06 |
| Date Received | 2006-04-27 |
| Date of Report | 2006-03-28 |
| Date of Event | 2006-02-10 |
| Date Mfgr Received | 2006-03-28 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2013-05-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DON HENTON |
| Manufacturer Street | 901 FRONT ST |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer G1 | FERRARIS RESPIRATORY INC |
| Manufacturer Street | 1301 COURTESY RD |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DC-II COLLINS FILTER |
| Generic Name | MOUTHPIECE FILTER FOR PULMONARY FUNCTION TEST |
| Product Code | BZC |
| Date Received | 2006-04-27 |
| Model Number | K022454 |
| Catalog Number | K022454 |
| Lot Number | 051705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FERRARIS RESPIRATORY INC |
| Manufacturer Address | 901 FRONT ST LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-27 |