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

Model Number DS5100C-PB

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

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 intermittent low baselines.They were getting low baselines on healthy patients.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The device passed the all test criteria.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: 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: 9121206
• MDR Text Key: 160261762
• Report Number: 2936999-2019-00786
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 10884521185906
• UDI-Public: 10884521185906
• Combination Product (y/n): N
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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 Model Number: DS5100C-PB
• Device Catalogue Number: DS5100C-PB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1