ACTIV.A.C. THERAPY SYSTEM Adverse Event — Malfunction (MDR 3009897021-2020-00164)
ACTIV.A.C. THERAPY SYSTEM Adverse Event — Malfunction (MDR 3009897021-2020-00164) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACTIV.A.C. THERAPY SYSTEM; Generic name: OMP; Manufacturer: KINETIC CONCEPTS, INC..
| Device | ACTIV.A.C. THERAPY SYSTEM |
|---|---|
| Generic name | OMP |
| Manufacturer | KINETIC CONCEPTS, INC. |
| Report number | 3009897021-2020-00164 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | MDR- 3009897021-2020-00164 SUBMITTED ON 28-APR-2020 REPORTED THE FOLLOWING IN H10 ADDITIONAL MANUFACTURER NARRATIVE: KCI IS REPORTING THIS EVENT FOUND DURING SERVICING OF THE UNIT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR. CORRECTION. KCI IS REPORTING THIS EVENT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR. |
| Source | openFDA MAUDE (device adverse events) |
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