MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-09-22 for COUGHASSIST CA-3000 manufactured by Respironics Georgia, Inc..
[15010043]
Info was received from a consumer alleging her husband may have contracted e. Coli bacteria in his lung from the use and setup of a coughassist device while being treated for als at the medical center. She stated she feels the setting was set too high for her husband's condition and she never saw a filter on the cough assist unit. Her husband's condition weakened and he later expired. Additional info was requested from the medical center but none was provided.
Patient Sequence No: 1, Text Type: D, B5
[15525957]
The serial number of the device was not reported and the device is not being returned to the mfr for evaluation. An attempt was made to obtain additional info from the medical center but none was provided. During this attempt, we also made the contact person at the medical center aware of the caution labeling requiring a new bacterial/viral filter to be attached to the patient circuit when using the device on a new patient. In addition, a follow-up letter was mailed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1040777-2008-00001 |
| MDR Report Key | 1174263 |
| Report Source | 04 |
| Date Received | 2008-09-22 |
| Date of Report | 2008-08-27 |
| Date of Event | 2008-08-01 |
| Date Mfgr Received | 2008-08-27 |
| Date Added to Maude | 2008-09-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT SHERBURN |
| Manufacturer Street | 175 CHASTAIN MEADOWS COURT |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704232322 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUGHASSIST |
| Generic Name | SECRETION CLEARANCE DEVICE |
| Product Code | NHJ |
| Date Received | 2008-09-22 |
| Model Number | CA-3000 |
| Catalog Number | CA-3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1202504 |
| Manufacturer | RESPIRONICS GEORGIA, INC. |
| Manufacturer Address | KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-09-22 |