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

Model Number SAFB

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

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 caused signs of burn.It was indicated that this resulted to a red tissue injury to the patient.

• 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
• Manufacturer (Section G): JABIL CIRCUIT(SHANGHAI) LTD; no 600 tian lin rd; shanghai 20023 ; CN 20023
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8593491
• MDR Text Key: 144543506
• Report Number: 2936999-2019-00331
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 20884521105901
• UDI-Public: 20884521105901
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K082327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2019

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: SAFB
• Device Catalogue Number: SAFB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/08/2019
• 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