MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. INFOV.A.C.¿ THERAPY SYSTEM; OMP

Model Number WNDINF

Device Problems Low Audible Alarm (1016); Complete Loss of Power (4015)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Date 05/01/2008

Event Type  Injury  

Event Description

The following information was received by kci after review of journal article: "the incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients", which noted the following under section results: "twelve patients (10%) had problems with the npwt device powering off causing an unrecognized interruption of therapy".Five patients underwent unplanned surgical irrigation and debridement for removal of non-viable or necrotic tissue.Unit was left unplugged depleting the device's battery power and the device shut off.As such, many medical machines, including the vac device, have an alarm that signals impending power failure.Medical alarms should be robust and the magnitude of devices alerting failures should be proportional to the potential complications caused by failure." on 06-sep-2022, the following information was provided to kci by the author/physician: no additional information regarding the article is available.The infov.A.C.¿ therapy system product identifiers were not available, therefore, device evaluations could not be performed.

Manufacturer Narrative

Age or date of birth and sex: patient identifier information for four additional patients are as follows: 57 year old male, 51 year old male, 53 year old male, and 34 year old female.Date of event: the specific date is unknown.The article noted patients included were orthopedic trauma patients treated with npwt between may-2008 and nov-2008.Therefore, 01-may-2008 was utilized.Based on the information available, it cannot be determined that the alleged unplanned surgical irrigation and debridement were related to the infov.A.C.¿ therapy system.The author was unable to provide additional clinical and device information.No device identifiers were available, therefore, device evaluations could not be performed.Device labeling, available in print and online, states: 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.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.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.

• Brand Name: INFOV.A.C.¿ THERAPY 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: 15494522
• MDR Text Key: 300759368
• Report Number: 3009897021-2022-00155
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: WNDINF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male