MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD INVOS; OXIMETER, TISSUE SATURATION

Model Number	5100C-EU
Medical Device Problem Code	False Reading From Device Non-Compliance (1228)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had erratic readings.The customer indicated that there was no patient involvement.No further information available.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation and the front case was broken.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure to the housing damage.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
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 1 upland rd; norwood MA 02062
• MDR Report Key: 7481056
• Report Number: 2936999-2018-00320
• Device Sequence Number: 1417788
• Product Code: MUD
• UDI-Device Identifier: 10884521211179
• UDI-Public: 10884521211179
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 5100C-EU
• Device Catalogue Number: 5100C-EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1