MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ACTIVECARE +SFT SYSTEM WARNING:; SLEEVE, LIMB, COMPRESSIBLE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(6).Once the investigation is completed, a follow-up/final report will be submitted.Device product code: jow.At this time, it can't be definitively determined whether this device had any malfunctions at all.

Event Description

It was reported that the device was causing physical pain to the patient during use and that she developed a blood clot while using the device.No additional consequences have been reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b1, b4, d4, d10, e1, g4, g7, h2, h3, h4, h6, h10.D4 - udi no.: ( (b)(4).The device history record (dhr) for activecare+sft unit serial number 18sft1272 was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.While evaluating the device, the technician was unable to confirm the reported event as he could not find a failure mode that was related to or could cause the reported event.Noted below were the only issues found during inspection.- power supply not returned for testing - clock time incorrect - battery wrap was torn the service technician then arranged, replaced the components noted below, and confirmed the device was functioning as intended.The device was tested, inspected, and repaired and device calibration was performed.Components replaced: - twist lock ¿ p/n (b)(4).- power supplier us type a ¿ p/n (b)(4).- battery pack assy gen b ¿ p/n (b)(4).Note the activecare+sft patient instructions for use (a385a001801) says that 'if you are unable to use the device for more than 5 hours, contact your physician immediately to prevent potential vte.' in addition, the idu recommends to check the skin of your legs at least once a day.If you experience any discomfort, pain, swelling, blistering, sensation changes, skin irritation, skin breakdown, or any other unusual reaction, consult your physician immediately and notify your service provider.Followup suggests the patient correctly followed the ifu and returned to treatment afterwards.Because the reported event could not be confirmed, it is not known with the information available what component could have caused the reported event.Therefore, a specific root cause cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action at this time, as this complaint is determined to not be a new confirmed quality or manufacturing issue.This complaint will be tracked and trended for any adverse trends that may require additional actions.

• Brand Name: ACTIVECARE +SFT SYSTEM WARNING:
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9198526
• MDR Text Key: 163317161
• Report Number: 0001526350-2019-00892
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• PMA/PMN Number: K151377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: A502B000101
• Device Lot Number: 64076838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other