MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for ACTIV.A.C.? THERAPY SYSTEM WNDACT manufactured by Kinetic Concepts, Inc..
[185099232]
Based on the information obtained regarding the device, kci found evidence that the device turned off and on due to a faulty power button. There is no injury associated with this event. Kci is reporting this event as a device malfunction that has the potential to result in injury if it were to recur. Device labeling, available in print and online, states: warnings keep v. A. C.? Therapy on: never leave a v. A. C.? Dressing in place without active v. A. C.? Therapy for more than two hours. If therapy is off for more than two hours, remove the old dressing and irrigate the wound. Either apply a new v. A. C.? Dressing from an unopened sterile package and restart v. A. C.? Therapy, or apply an alternate dressing at the direction of the treating physician.
Patient Sequence No: 1, Text Type: N, H10
[185099233]
On 22-feb-2020, the following information was reported to kci by the nurse: the activ. A. C.? Therapy system allegedly self-shuts down. On 14-feb-2020, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications prior to patient placement. On (b)(6) 2020, the device was placed with the patient. On (b)(6) 2020, kci quality engineering performed an evaluation of the device. It was identified that the device powered off and on due to a faulty power button.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2020-00102 |
| MDR Report Key | 9879998 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2014-06-18 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Returned To Mfg | 2020-02-22 |
| Model Number | WNDACT |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-25 |