MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for INSPIRA AIR BC1440A manufactured by Acclarent, Inc..
[96972145]
Patient Sequence No: 1, Text Type: N, H10
[96972146]
The balloon system was being used to dilate the trachea. The balloon popped when air was inflated into it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7181683 |
| MDR Report Key | 7181683 |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-12-29 |
| Report Date | 2018-01-02 |
| Date Reported to FDA | 2018-01-02 |
| Date Reported to Mfgr | 2018-01-02 |
| Date Added to Maude | 2018-01-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA AIR |
| Generic Name | BRONCHOSOCPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2018-01-11 |
| Model Number | BC1440A |
| Catalog Number | BC1440A |
| Lot Number | 170607A-PC |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DR IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |