MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD INVOS PATIENT MONITORING

Model Number PMPAMP71

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

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 devices had reading issue.It was stated that the monitor showed low baseline and erratic rso2 reading fluctuating by 40-50% from baseline unilaterally and on both sides.It was stated that first baselines were 20 and 24.Sensors were removed and new ones applied resulting in baselines of 28 and 30.Baselines reading were set on an awake patient receiving 6 lpm of oxygen.It was reported that there was no patient injury.

• Brand Name: INVOS PATIENT MONITORING
• 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: 8422609
• MDR Text Key: 139046717
• Report Number: 2936999-2019-00187
• Device Sequence Number: 1
• Product Code: QEM
• UDI-Device Identifier: 10884521552616
• UDI-Public: 10884521552616
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

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: PMPAMP71
• Device Catalogue Number: PMPAMP71
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• 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 Age: 60 YR