HOMEPUMP ECLIPSE Adverse Event — Malfunction (MDR 2026095-2020-00062)
HOMEPUMP ECLIPSE Adverse Event — Malfunction (MDR 2026095-2020-00062) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HOMEPUMP ECLIPSE; Generic name: ELASTOMERIC HFR; Manufacturer: AVANOS MEDICAL - IRVINE.
| Device | HOMEPUMP ECLIPSE |
|---|---|
| Generic name | ELASTOMERIC HFR |
| Manufacturer | AVANOS MEDICAL - IRVINE |
| Report number | 2026095-2020-00062 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, FOREIGN, OTHER |
| Narrative | THE DEVICE HISTORY RECORD FOR LOT 0202906485 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 08 JUL 2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPO |
| Source | openFDA MAUDE (device adverse events) |
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