MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for ACTIV.A.C.? THERAPY SYSTEM WNDACT manufactured by Kinetic Concepts, Inc..
[185707549]
Based on the information obtained regarding the device, kci found evidence that the device had a collapsed dome. There is no injury associated with this event. 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.
Patient Sequence No: 1, Text Type: N, H10
[185707550]
On (b)(6) 2020, kci technical services identified a power switch with collapsed dome. On (b)(6) 2020, kci quality engineering performed an evaluation of the device. Inspection of the device found the power button was collapsed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2020-00135 |
| MDR Report Key | 9890703 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. STEVEN JACKSON |
| Manufacturer Street | 6203 FARINON DRIVE |
| Manufacturer City | SAN ANTONIO, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 2556438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIV.A.C.? THERAPY SYSTEM |
| Generic Name | OMP |
| Product Code | OMP |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-02-06 |
| Model Number | WNDACT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINETIC CONCEPTS, INC. |
| Manufacturer Address | SAN ANTONIO, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |