MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-08 for AUTOMATED IMPELLA CONTROLLER IMPELLA AIC CONTROLLER 0042-0000-US manufactured by Abiomed, Inc..
[135682275]
The device was received and an investigation is underway. Should analysis identify a failure of the device to operate to specification, a supplemental mdr will be filed with the results of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135682276]
The complainant reported a (b)(6) year old caucasian male presenting with right ventricular failure, post left ventricular assist device implantation. The impella rp was inserted for cardiac support. During the procedure, the automated impella controller (aic) console emitted a controller failure alarm, resulting in an unexpected shutdown. Subsequently, the patient became unstable and coded. As treatment, patient was administered medical intervention via inotopes and pressors (medication). Pump was switched to a back- up aic console, and patient became stable. The procedure was completed successfully, thereafter, with no lasting harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2019-00027 |
| MDR Report Key | 8323896 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-08 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-01-12 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2015-07-21 |
| Date Added to Maude | 2019-02-08 |
| 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. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DR. |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED, INC. |
| Manufacturer Street | 22 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 | AUTOMATED IMPELLA CONTROLLER |
| Generic Name | AUTOMATED IMPELLA CONTROLLER |
| Product Code | PYX |
| Date Received | 2019-02-08 |
| Returned To Mfg | 2019-01-15 |
| Model Number | IMPELLA AIC CONTROLLER |
| Catalog Number | 0042-0000-US |
| Lot Number | 1198722 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR. DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-02-08 |