MAUDE Adverse Event Report: JABIL CIRCUIT(SHANGHAI) LTD INVOS; OXIMETER, TISSUE SATURATION

Model Number SAFB-SM/INTL

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the device¿s measurement value started to dropped at the middle of the surgery and remained to the lowest value.No increased in value was seen even during patient recovery.Sensor was replaced with a new one and the value increased.There was no patient injury.

Manufacturer Narrative

The returned sensor was reported as ¿during use, the device¿s measurement value started to dropped at the middle of the surgery and remained to the lowest value.No increased in value was seen even during patient recovery.Sensor was replaced with a new one and the value increased.There was no patient injury¿.The test-bed device was connected to ac power.The ac power illuminated.The test-bed device was powered on and passed.The test-bed device was tested for proper operation using a pre-amplifier and a field test device and was observed to operate as specified.A visual inspection was carried out on the returned sensor.No anomalies were observed.The sensor was connected to a reusable sensor cable, the pre-amplifier and the test-bed device.The sensor failed with the following error message 'poor signal quality' coming up on the display screen, and no values could be obtained.The sensor was tested as per the post assembly test procedure, where it was observed that the sensor was passing ¿noise¿ but failing ¿shallow¿ at ¿functional¿.The failing component was located on the adult sensor.Which by design, was a flexible printed circuit board.The sensor was sent to the vendor for analysis.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure of the observed condition to the defective sensor.Information has been added to the database and trends will continue to be monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): JABIL CIRCUIT(SHANGHAI) LTD; no 600 tian lin rd; shanghai 20023 ; CN 20023
• MDR Report Key: 9238686
• MDR Text Key: 164237923
• Report Number: 2936999-2019-00893
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 20884521104225
• UDI-Public: 20884521104225
• Combination Product (y/n): N
• PMA/PMN Number: K082327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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 Model Number: SAFB-SM/INTL
• Device Catalogue Number: SAFB-SM/INTL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1