HEARTMATE MOBILE POWER UNIT, NA Adverse Event — Malfunction (MDR 2916596-2020-02143)
HEARTMATE MOBILE POWER UNIT, NA Adverse Event — Malfunction (MDR 2916596-2020-02143) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE MOBILE POWER UNIT, NA; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE MOBILE POWER UNIT, NA |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02143 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | SECTION H5: CORRECTION. SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF BROKEN PIN IN A MOBILE POWER UNIT (MPU) PATIENT CABLE WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE BENT PINS. THE CABLE WAS REPLACED AND THE MPU WENT THROUGH A FULL FUNCTIONAL CHECKOUT BEFORE BEING RETURNED TO THE CUSTOMER SITE. THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT D |
| Source | openFDA MAUDE (device adverse events) |
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