MAUDE Adverse Event Report: LD TECHNOLOGY LLC ANS-1; OXIMETER

Model Number A1VSV133

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/04/2019

Event Type  Injury  

Event Description

Tm-flow report (https://www.Ldteck.Com/ans-1) indicated poor cardiac output and ans dysfunction which the pt didn't have.The equipment constantly malfunctions each time it is turned on.Either the pulse ox or one or several of the blood pressure cuffs does not work.They have been reset many times by it and malfunction again once the system is booted up the next time.Ld tech is pushing device that doesn't seem to produce reliable test results for use in diagnosis of cardiac and neuropathy dysfunctions.Fda safety report id# (b)(4).

• Brand Name: ANS-1
• Type of Device: OXIMETER
• Manufacturer (Section D): LD TECHNOLOGY LLC
• MDR Report Key: 9123949
• MDR Text Key: 160304423
• Report Number: MW5090042
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1VSV133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 58