ACTIV.A.C.? THERAPY SYSTEM WNDACT

MAUDE Adverse Event Report

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 2020-03-26 for ACTIV.A.C.? THERAPY SYSTEM WNDACT manufactured by Kinetic Concepts, Inc..

Event Text Entries

[185098727] Based on the information obtained regarding the device, kci found evidence that the device had a collapsed power switch. 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


[185098728] On 11-feb-2020, the following information was reported to kci by the physician: the activ. A. C.? Therapy system allegedly powers off randomly. On 20-nov-2019, 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) 2019, the device was placed with the patient. On (b)(6) 2020, kci quality engineering performed an evaluation of the device found the power button was collapsed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009897021-2020-00124
MDR Report Key9884076
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-11
Date Mfgr Received2020-02-25
Device Manufacturer Date2016-05-30
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. STEVEN JACKSON
Manufacturer Street6203 FARINON DRIVE
Manufacturer CitySAN ANTONIO, TX
Manufacturer CountryUS
Manufacturer Phone2556438
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIV.A.C.? THERAPY SYSTEM
Generic NameOMP
Product CodeOMP
Date Received2020-03-26
Returned To Mfg2020-02-11
Model NumberWNDACT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKINETIC CONCEPTS, INC.
Manufacturer AddressSAN ANTONIO, TX US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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