MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-15 for E70 COUGH ASSIST 1098159 manufactured by Respironics, Inc..
[145133219]
The manufacturer received information alleging a e70 cough assist delivered high inspiratory pressure and failed to deliver the negative pressure required to clear the patient's secretions. There was report of patient harm or injury. An investigation is still ongoing. A follow up report will be filed when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1040777-2019-00022 |
| MDR Report Key | 8612504 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-06-21 |
| Device Manufacturer Date | 2012-12-14 |
| Date Added to Maude | 2019-05-15 |
| 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 Contact | MR. ADAM PRICE |
| 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 156683724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 156683724 |
| 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 | 2019-05-15 |
| Returned To Mfg | 2019-04-15 |
| Model Number | 1098159 |
| Catalog Number | 1098159 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 175 CHASTIAN MEADOWS COURT KENNESAW GA 301443724 US 301443724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |