MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-02-13 for INNOSPIRE ELEGANCE 1099973 manufactured by Respironics Respiratory Drug Delivery (uk) Ltd.
| Report Number | 9681154-2020-00002 |
| MDR Report Key | 9706059 |
| Report Source | FOREIGN |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2020-02-13 |
| 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 | ADAM PRICE |
| Manufacturer Street | CHICHESTER BUSINESS PARK CITY FIELDS WAY, TANGMERE |
| Manufacturer City | CHICHESTER, PO202FT |
| Manufacturer Country | UK |
| Manufacturer Postal | PO20 2FT |
| Manufacturer G1 | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| Manufacturer Street | CHICHESTER BUSINESS PARK CITY FIELDS WAY, TANGMERE |
| Manufacturer City | CHICHESTER, PO202FT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PO20 2FT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOSPIRE ELEGANCE |
| Generic Name | COMPRESSOR, AIR, PORTABLE |
| Product Code | BTI |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-06 |
| Model Number | 1099973 |
| Catalog Number | 1099973 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| Manufacturer Address | CHICHESTER BUSINESS PARK CITY FIELDS WAY, TANGMERE CHICHESTER, PO202FT UK PO20 2FT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |