MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD UNKINVOS

Model Number UNSPECIFIED INVOS PRODUCT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the nurse noted that there was slight pressure injury from the device.

• Brand Name: UNKINVOS
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; no 600 tian lin road; shanghai,20 20023 3; CN 200233
• Manufacturer (Section G): JABIL CIRCUIT (SHANGHAI) LTD; no 600 tian lin road; shanghai,20 20023 3; CN 200233
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8542144
• MDR Text Key: 142865353
• Report Number: 2936999-2019-00305
• Device Sequence Number: 1
• Product Code: QEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNSPECIFIED INVOS PRODUCT
• Device Catalogue Number: UNSPECIFIED INVOS PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other