MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-07 for ABBOTT manufactured by Abbott.
[130198489]
Pt presented with multiple vad pump stop, low flow alarms, and warnings to replace controller - which had been happening since (b)(6) 2018. He was admitted to hosp for perc lead repair. This was completed on (b)(6) 2018. Pt continued to have alarms over the weekend and underwent hm2 pump exchange on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8155418 |
| MDR Report Key | 8155418 |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-10-10 |
| Date Facility Aware | 2018-10-24 |
| Report Date | 2018-12-04 |
| Date Reported to FDA | 2018-12-04 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ABBOTT |
| Generic Name | HEARTMATE 2 LVAD |
| Product Code | OKR |
| Date Received | 2018-12-07 |
| Returned To Mfg | 2018-10-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | 6035 STONERIDGE DR. PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2018-12-07 |