MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

Device Problem Unintended Electrical Shock (4018)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 08/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided by the patient's family member: the activ.A.C.¿ ion progress¿ remote therapy monitoring system power cord allegedly broke during the night and the patient was electrocuted.The patient had to go to the emergency room.On (b)(6) 2022, the following information was provided by the patient: while at home, the patient went to unplug the power cord and was allegedly electrocuted and lost consciousness.The patient was transported to the hospital by ambulance, admitted to the burn unit, and was reportedly being evaluated for internal muscular damage.V.A.C.® therapy was still being utilized.On (b)(6) 2022, the following information was provided by the hospital representative: the patient was admitted to blocker burn unit on (b)(6) 2022 for one day.No further information was provided.On (b)(6) 2022, the following information was obtained from clinical documents received by the hospital: on (b)(6) 2022, the patient presented to the emergency department and was subsequently admitted to the burn intensive care unit for higher quality of care.Upon admission the patient's labs and physical exam were within normal limits and after observation was discharged for follow up care.The patient reported he may have carpel tunnel syndrome.The patient did not report any new difficulties or worsening of previous injuries, only soreness to his thumb, and no loss of consciousness was reported or documented.The patient was diagnosed with a second-degree superficial burn.The patient has not been seen or had a follow up appointment scheduled since discharge.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system and associated power cords is pending return of the equipment.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged electrical shock resulting in second degree burn is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.A device evaluation is pending equipment return.Device labeling, available in print and online, states: warnings: important information for users: in order for kci products to perform properly, kci recommends the following conditions.Use this product only in accordance with this manual and applicable labeling.Ensure the electrical installation of the room complies with the appropriate national electrical wiring standards.Do not operate this product if it has damaged power cord, power supply or plug.If these components are worn or damaged, contact kci.Do not drop or insert any object into any of the opening or tubing of this product.Keep the unit away from heated surfaces.Do not modify the therapy unit or dressing.Do not connect this product or its components to devices not recommended by kci.Avoid spilling fluids on any part of this product.Fluids remaining on the electrical controls can cause corrosion that may cause the electronic components to fail.Component failures may cause the unit to operate erratically, possibly producing potential hazards to patient and staff.If spills do occur, unplug the unit immediately and clean with an absorbent cloth.Ensure there is no moisture in or near the power connection and power supply components before reconnecting power.If the product does not work properly, contact kci.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

Event Description

On 03-nov-2022, the following information was provided by kci quality engineering.On 15-jul-2022, the device and power cords were tested per quality control procedure by kci service center, passed and met specifications.On (b)(6) 2022, the device was placed with the patient.The patient declined to return the device and power cords, therefore, a device evaluation could not be performed.

Manufacturer Narrative

Based on the additional information regarding the device and power cords, kci's assessment remains the same: it cannot be determined that the alleged electrical shock resulting in second degree burn is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device and power cords passed quality control checks before patient placement, and a device evaluation after placement could not be performed.

• 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 Key: 15427163
• MDR Text Key: 299948800
• Report Number: 3009897021-2022-00148
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 93 KG