MAUDE Adverse Event Report: MMJ SA DE CV (USD) BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device did not read correctly.The customer indicated no patient harm.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8961034
• MDR Text Key: 156481886
• Report Number: 2936999-2019-00681
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 10884521134300
• UDI-Public: 10884521134300
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2019
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0924171K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/04/2019
• Date Device Manufactured: 09/24/2017
• 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