* Adverse Event — Malfunction (MDR 9616240-2008-00005)
* Adverse Event — Malfunction (MDR 9616240-2008-00005) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: *; Generic name: *; Manufacturer: GAMBRO DASCO S.P.A., MONITOR DIVISION.
| Device | * |
|---|---|
| Generic name | * |
| Manufacturer | GAMBRO DASCO S.P.A., MONITOR DIVISION |
| Report number | 9616240-2008-00005 |
| Event type | Malfunction |
| Date received | 2008-01-22 |
| Report source | Health Professional, User facility, Company representation |
| Narrative | IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTIONS HAVE BEEN DESIGNED AND VALIDATED AND ARE CURRENTLY BEING INTRODUCED IN THE FIELD TO AVOID THE OCCURRENCE OF TUBING DISCONNECTION. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY. |
| Source | openFDA MAUDE (device adverse events) |
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