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 2020-02-28 for EVEREST INFLATION DEVICE 30ATM AC3200 manufactured by Medtronic, Inc.
[182917525]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182917526]
An everest inflation device was used during a procedure. There was no damage noted to the packaging. The device was removed from packaging per ifu with no issues. The device was prepped per ifu with no issues. It was reported that there was a piston/knob issue. The pistol part of the device did not work during the procedure and this caused difficulty in deflation. The device was not connected to a mating device at the time of the alleged issue. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
[188519118]
It was reported that the trigger part of the device did not work during the procedure. There was a difficulty pulling back the piston knob because the quick trigger did not work, and this caused difficulty in deflation. The device was been operated per ifu. The everest device was connected to an unknown brand sc balloon at the time of the alleged issue. The everest was replaced with another everest of the different lot. The balloon deflated when using the replacement everest device. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2020-00030 |
| MDR Report Key | 9768154 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-12-02 |
| Date Added to Maude | 2020-02-28 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVEREST INFLATION DEVICE 30ATM |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2020-02-28 |
| Catalog Number | AC3200 |
| Lot Number | 60216614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |