MAUDE Adverse Event Report: UNKNOWN SMART TOOLS BFR PUMP; TOURNIQUET, PNEUMATIC

Device Problems Product Quality Problem (1506); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

There had been reports for years that this company was supplying faulty manometers/sphygmomanometers.These manometers were used to inflate tourniquet cuffs and needed to be accurate.The website now says that covid has created a supply chain disruption so they will be distributing another non-fda listed manometer/sphygmomanometer.(b)(6) they are also distributing a non-fda listed automatic pump: (b)(6)/preorder/ without accurate calibration frequently, these automatic pumps could cause extreme injury to patients.Fda safety report id #: (b)(4).

• Brand Name: SMART TOOLS BFR PUMP
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10245216
• MDR Text Key: 198409381
• Report Number: MW5095424
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability