MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-06 for COUGH ASSIST 1098160 manufactured by Respironics Inc.
[5550473]
The manufacturer received information alleging a coughassist t70 device stopped working properly while in use with a tracheostomy patient. The patient had a medical history of amyotrophic lateral sclerosis (als) and expired while using the device. The device was returned to the manufacturer's service center. The manufacturer found the device to operate to design specifications. The device cycled properly on inhalation and exhalation. During the evaluation of the returned device, the device's air path was observed to be contaminated with talc type white powdery substance. The origin of this contaminant is unknown, but this contamination did not affect the device's ability to provide therapy. The intended use of the coughassist t70 device: the respironics cough assist t70 is intended for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home. The manufacturer concludes the device did not cause the reported adverse event. It appears the patient's medical condition contributed to the patient's outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1040777-2015-00015 |
| MDR Report Key | 4578219 |
| Report Source | 05,06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-01-22 |
| Date Mfgr Received | 2015-02-09 |
| Device Manufacturer Date | 2014-03-28 |
| Date Added to Maude | 2015-03-06 |
| 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 | MR. WILFREDO ALVAREZ |
| Manufacturer Street | 1740 GOLDEN MILE HIGHWAY |
| Manufacturer City | MONROEVILLE 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243875658 |
| Manufacturer G1 | RESPIRONICS INC |
| Manufacturer Street | 175 CHASTAIN MEADOWS COURT |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUGH ASSIST |
| Generic Name | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
| Product Code | NHJ |
| Date Received | 2015-03-06 |
| Returned To Mfg | 2015-03-04 |
| Model Number | 1098160 |
| Catalog Number | 1098160 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC |
| Manufacturer Address | 175 CHASTAIN MEADOWS COURT KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-03-06 |