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| Model Number WNDACT |
| Device Problems
No Audible Alarm (1019); Alarm Not Visible (1022); Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Unexpected Shutdown (4019)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 04/23/2017 |
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Event Type
malfunction
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Manufacturer Narrative
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Based the investigation to date, kci quality engineering found evidence that the unit would not power on which is consistent with customer allegation.Kci has made multiple attempts to gather further information, but no information was been received at this time.A review of the device history logs is pending.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals and instillation therapy parameters (for the v.A.C.Instill¿ system).Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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.It is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active, if not: if you find that the seal is broken and the v.A.C.® drape has become loose, trim away any loose or moist edges, ensure the skin is dry and then apply new drape strips.Note: if a leak source is identified, patch with additional drape to ensure seal integrity.V.A.C.® therapy may not be off any longer than two hours per day.
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Event Description
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On (b)(6) 2017, the following information was reported to kci by the home health nurse: the patient allegedly developed an infection to the wound.The unit's screen was freezing and then the unit would self shut down.The unit was off for 10 hours with the patient being unaware.On (b)(6) 2017, the following information was reported to kci by the home health nurse: the patient's wound developed an infection on (b)(6) 2017.The unit was shutting off and was hard to turn back on.The patient went without therapy, which allegedly caused the infection.The physician ordered the patient be placed on antibiotic therapy and the activ.A.C.¿ therapy (system) was placed on hold until the course of antibiotics was completed.The patient was placed on an alternate dressing during that time.The patient's course of antibiotics was completed and the wound infection resolved.Activ.A.C.¿ therapy was restarted with a replacement unit.The patient's wound, at last dressing change, was making progress and had decreased in size with a good healthy beefy red appearance.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci quality engineering.Functional testing could not be performed as the unit's screen would freeze during boot up and the unit would shut off.Inspection and testing of the device is consistent with the customer allegation.Additional investigation of the unit is pending.
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Manufacturer Narrative
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Based on the additional information obtained regarding the device, kci determined that evidence was found that confirmed the unit would not power on which is consistent with customer allegation.Kci has made multiple attempts to gather further information, but no information was been received at this time.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals and instillation therapy parameters (for the v.A.C.Instill¿ system).Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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.It is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active, if not: if you find that the seal is broken and the v.A.C.® drape has become loose, trim away any loose or moist edges, ensure the skin is dry and then apply new drape strips.Note: if a leak source is identified, patch with additional drape to ensure seal integrity.V.A.C.® therapy may not be off any longer than two hours per day.
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Event Description
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On (b)(6) 2017, a review of the event logs that were retrieved from the device by kci qe found that the patient did not receive active therapy for time periods ranging from 2 hours to 11 days.It could not be determined whether the patient manually turned off the unit or if the unit self shut down as event records show therapy being turned on followed by the unit shutting off with no record of therapy being turned off.Further investigation is pending.
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Manufacturer Narrative
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Based on the additional information obtained regarding the device, kci's determination remains the same.Evidence was found that confirmed a faulty simtek chip that caused the device to shut off and made it hard to restart.The investigation confirmed the customer's allegation of the unit self-shutting down and hard to turn on.
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Event Description
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On feb 6 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On may 22 2017, the device was tested per quality control (qc) procedure by kci quality engineering, who determined that the unit would freeze at the kci logo screen and then shut off.The evaluation also confirmed, that the unit's controller board contained a faulty simtek chip (part number: cy14b101k/stk17ta8) that was causing the unit to shut off and made it hard to restart.Therefore, inspection and testing of the device did reveal evidence of an operational malfunction with the unit.
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Manufacturer Narrative
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Correction: date of event: corrected from (b)(6) 2017.Correction: mdr-3009897021-2017-00068_fu2 sent on (b)(6) 2017 noted report type: product problem.Correction: adverse event.Based on the information provided, it cannot be determined that the alleged infection is related to activ.A.C.¿ therapy.A malfunction of the unit was not confirmed.In addition, this investigation ruled out the simtek chip as a potential cause as originally reported.
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Event Description
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Final investigation results: on 06-feb-2017, the device was tested per quality control procedure by kci field service, and the unit passed the quality control checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On 22-may-2017, the device was tested per quality control procedure by kci quality engineering, who confirmed that the unit would freeze and not power on.Based on the device log review, kci confirmed the unit shut down with no alarm on (b)(6) 2017, approximately one week prior to the customer report to kci.Through internal testing, it was confirmed the unit was hard to restart.A cross functional investigation was not able to identify a potential root cause for the reported complaint.A malfunctioning component was not identified during the evaluation of the device.
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Manufacturer Narrative
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Correction: based on further investigation performed by kci, the simtek chip was ruled out as a potential cause of the unit self-shutting down with no alarm and the unit being hard to restart.The final investigation did not reveal a definitive cause of the event.
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Event Description
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Kci performed an additional evaluation of the device that ruled out the simtek chip as a potential cause for the unit self-shutting down with no alarm and the unit being hard to restart.The inspection and testing of the device confirmed an operational malfunction with the device; however, a definitive cause of the event could not be determined.
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