MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for HEARTWARE HVAD 1103 manufactured by Heartware.
[40639811]
Per the incident report completed: "pt disconnected both power sources to her heartware lvad, causing pump stop, this morning while attempting to get out of bed to the restroom at home. Pt passed out and hit her head. Husband was nearby and quickly reconnected lvad power. Assumed pump stop time was less than 1 minute. Pt is on coumadin and asa with inr approx 2. Pt developed confusion and n/v shortly after fall. Upon arrival to ed, pt had waxing/waning mental status. Confirmation of traumatic intra-cranial bleed by ct scan. Taken to operating room for decompression and evacuation of hematoma by neurosurgery. " on (b)(6)2016 she had a frontal bolt 2/20 for monitoring of icp. Pt continued to decline with no meaningful neurological recovery. Pt's husband decided to withdraw care with support from medical team. Pt expired on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060922 |
| MDR Report Key | 5506753 |
| Date Received | 2016-03-14 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-02-23 |
| Date Added to Maude | 2016-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | HEARTWARE HVAD |
| Generic Name | HEARTWARE HVAD |
| Product Code | OKR |
| Date Received | 2016-03-14 |
| Model Number | 1103 |
| Lot Number | CON93809 |
| Device Expiration Date | 2016-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE |
| Manufacturer Address | FRAMINGHAM CT 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2016-03-14 |