MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2018

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 unit had low readings.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received and inspected.The sensor was tested and failed.An impedance check was performed and all electrodes passed the impedance check.The sensor was visually inspected- no physical anomalies were found, and witness marks were observed.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.

Event Description

According to the reporter, the unit had very low readings when the patient was sober.Customer reported that there was no patient injury.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SG 554910
• Manufacturer (Section G): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SG 554910
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7828100
• MDR Text Key: 118756848
• Report Number: 2936999-2018-00541
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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: 07/15/2019
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0115181K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• 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