MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C. CANISTER; OMP

Model Number VACDSP

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Multiple Fractures (4519)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Code explanation "the activ.A.C.¿ canister was discarded and the lot number is unknown; therefore, neither a device evaluation nor a device history record review could be performed.Based on information provided, it cannot be determined that the fall and subsequent fractured ribs is related to the activ.A.C.¿ canister.The patient was on multiple medications that could increase the patient's risk of falling with side effects such as dizziness, fainting, lightheadedness, drowsiness, and difficulty concentrating/confusion.The patient stated he had "no issues with the vac".This event is being reported due to potential use error.Device labeling, available in print and online, states: carrying case: use the adjustable strap to wear the carrying case across your chest.Keep the therapy unit in the carrying case when in use.Tubing storage straps are provided.Fall prevention tips.Follow these safety tips to help prevent slips or falls while using the v.A.C.® therapy system: know your surroundings.Avoid possible tripping hazards, such as throw rugs, extension cords, and uneven floors.Safely store and secure any excess power cord and tubing to prevent tripping.See the therapy unit user manual for how to properly secure tubing.Be cautious of door knobs and other household objects that could catch exposed tubing.

Event Description

On 09-aug-2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient was admitted to the hospital allegedly due to tripping over the activ.A.C.¿ ion progress¿ remote therapy monitoring cord and broke four ribs.The wound care nurse reapplied the activ.A.C.¿ ion progress¿ remote therapy monitoring system on (b)(6) 2021.The patient stated he had "no issues with the vac".On 18-aug-2021, the following the information was reported to kci by the nurse: the patient allegedly tripped over the activ.A.C.¿ canister tubing and fell, causing four hairline fractures to the patient's ribs.Chest x-rays were taken to confirm.There was no medical or surgical intervention required.The patient was discharged from the emergency room and placed back on v.A.C.® therapy.The activ.A.C.¿ canister was discarded and the lot number is unknown; therefore, neither a device evaluation nor a device history record review could be performed.

• Brand Name: ACTIV.A.C. CANISTER
• 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: 12436579
• MDR Text Key: 274094234
• Report Number: 3009897021-2021-00218
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2021

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
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR