MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-03-30 for E70 COUGH ASSIST 1098163 manufactured by Respironics Inc.
[41480343]
The manufacturer received information alleging a patient using an e70 cough assist was diagnosed with bilateral pneumothorax. It is unknown at this time if the e70 cough assist caused or contributed to the patient's condition. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
[49455063]
The manufacturer previously reported an e70 cough assist was being used on a patient. The patient allegedly developed bilateral pneumothorax. The device is not being returned to the manufacturer for evaluation. The customer did not allege any device malfunction. The patient did not require medical attention. Product labeling states, "any patient with a history of bullous emphysema, known susceptibility to pneumothorax or pnuemo-mediastinum, or known to have had any recent barotrauma, should be carefully considered before use. " the manufacturer concludes there was no malfunction of the device. It appears the patient's medical condition contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1040777-2016-00011 |
| MDR Report Key | 5535772 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-07-12 |
| Device Manufacturer Date | 2014-02-03 |
| Date Added to Maude | 2016-03-30 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILFREDO ALVAREZ |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E70 COUGH ASSIST |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-24 |
| Model Number | 1098163 |
| Catalog Number | 1098163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2016-03-30 |