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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KINETIC CONCEPTS, INC ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM; OMP
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KINETIC CONCEPTS, INC ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM; OMP Back to Search Results
Model Number WNDARM
Device Problem Collapse (1099)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
During the repair process, kci found evidence that the device had a collapsed power switch dome.There is no patient involvement and there is no injury reported to kci 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 the malfunction were to recur.
 
Event Description
On (b)(6) 2021, kci identified the activ.A.C.¿ ion progress¿ remote therapy monitoring system had a collapsed power button/switch during the repair process.There is no patient or injury associated with this event.
 
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Brand Name
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
Type of Device
OMP
Manufacturer (Section D)
KINETIC CONCEPTS, INC
san antonio TX 78249
Manufacturer Contact
steven jackson
6203 farinon drive
san antonio, TX 78249
2102556438
MDR Report Key11970717
MDR Text Key258700356
Report Number3009897021-2021-00131
Device Sequence Number1
Product Code OMP
UDI-Device Identifier00849554005600
UDI-Public0100849554005600
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberWNDARM
Device Catalogue Number416909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3009897021-5-15-20-001-C
Patient Sequence Number1
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