MAUDE Adverse Event Report: KINETIC CONCEPTS, INC ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	RTMGSM01/US
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the following information was provided by the patient: the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring allegedly made her wound worse.On 22-oct-2025, the following information was provided by the medical assistant: on(b)(6) 2025, the patient was seen in the office and reported malfunctions with the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring, including fluid accumulation under the v.A.C.® drape.The wound exhibited redness and signs and symptoms of infection, along with fluid collection beneath the v.A.C.® drape.The patient required overnight hospitalization for observation and was treated with intravenous antibiotics.V.A.C.® therapy was discontinued.The patient is improving.On 15-aug-2025, the device was tested per quality control procedure by a solventum service center, and the device passed the quality control checks and met specifications prior to patient placement.On (b)(6) 2025, the device was placed with the patient.On (b)(6) 2025, the device was tested per quality control procedure by solventum quality engineering, and no failures were found with the device related to this event.
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the reported wound worsening, hospitalization, and infection requiring intravenous antibiotics are related to the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring.Prior to placement of v.A.C.® therapy, the patient had a history of preexisting infection and uncontrolled diabetes.The patient¿s provider emphasized the importance of diabetes management to prevent further wound complications.The device passed the quality control checks prior to patient placement, and no failures were found with the device related to this event.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 alternative dressing at the direction of the treating physician.Dressing changes wounds being treated with the v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48-72 hours, but no less than 3 times a week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.Deterioration of the wound if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: -check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.-clean wound more thoroughly during dressing changes.-evaluate for signs and symptoms of infection and, if present, treat accordingly.-change dressing often, ensuring that it is being changed at least every 48 hours.-examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.-assess for osteomyelitis and, if present, treat accordingly.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 or Problem Description
On (b)(6) 2025, the device was tested per quality control procedure by a solventum service center, and the device passed the quality control checks and met specifications prior to patient placement.On (b)(6) 2025, the device was placed with the patient.On (b)(6) 2025, the device was tested per quality control procedure by solventum quality engineering, and no failures were found with the device related to this event.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 23485324
• Report Number: 3009897021-2025-00052
• Device Sequence Number: 10559110
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K201571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RTMGSM01/US
• Device Catalogue Number: RTMGSM01/US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL SULFATE 90MCG/ACT 1-2 PUFFS Q 4HRS PRN.; AMLODIPINE 5MG 1 TAB PD DAILY.; ASPIRIN 81MG 1 TAB DAILY.; ATORVASTATIN CALCIUM 80MG 1 TAB Q HS AT HS.; CLINDAMYCIN 300MG 1 CAP QID.; CLONIDINE HCL 0.1MG 1 TAB PO DAILY PRN HTN.; CYMBALTA DR 60MG 1 TAB PO DAILY.; DOXYCYCLINE 100MG 1 TAB BID FOR 7 DAYS.; EMPAGLIFLOZIN 25MG 1 TAB PO DAILY.; EVOLOCUMAB 140MG/ML ADMIN 1 ML SQ EVERY 14 DAYS.; HUMALOG KWIKPEN INSULIN PER SLIDING SCALE.; LASIX 40MG TAKE 1 TAB PO DAILY.; NOVOLOG FLEXPEN PER SLIDING SCALE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female