MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD 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 09/24/2019

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 could not provide correct readings.The customer indicated no patient harm.

Manufacturer Narrative

Evaluation summary: one device was inspected.The device failed to meet specification as it was received or made available for evaluation.The device was visually inspected and no physical anomalies were found.The device was tested with a sensor lot code tester; the device was within expiration date and displayed a ¿sensor valid¿ message.An impedance check was performed using a digital multimeter, and all electrodes passed the impedance check.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 1 upland rd; norwood MA 02062
• MDR Report Key: 9236255
• MDR Text Key: 163707293
• Report Number: 2936999-2019-00892
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2020
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 1209181K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1