MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-04 for ARNDT ENDOBRONCHIAL BLOCKER SET G13279 C-AEBS-5.0-50-SPH manufactured by Cook Inc.
[165381048]
(b)(6). Occupation: assistant chief inahlo. Pma/510(k) #: k160542. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[165381049]
It was reported that the balloon in an arndt endobronchial blocker set did not inflate evenly. The balloon only inflated on one side. Another balloon was needed to complete the procedure. The procedure being performed was an isolation of the lung for thoracic surgery. No other adverse effects have been reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02766 |
| MDR Report Key | 9273405 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-04 |
| Date of Report | 2019-11-04 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2019-10-25 |
| Device Manufacturer Date | 2019-05-06 |
| Date Added to Maude | 2019-11-04 |
| 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. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARNDT ENDOBRONCHIAL BLOCKER SET |
| Generic Name | CBI TUBE, TRACHEAL/BRONCHIAL |
| Product Code | CBI |
| Date Received | 2019-11-04 |
| Model Number | G13279 |
| Catalog Number | C-AEBS-5.0-50-SPH |
| Lot Number | 9716354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-04 |