MAUDE Adverse Event Report: MASIMO CORP MASIMO DISPOSABLE PEDS OXIMETRY SENSOR

Catalog Number 2329

Device Problems False Reading From Device Non-Compliance (1228); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

When we use the peds disposable masimo oximetry sensors in conjunction with the ge pdm (patient data module) and b850 monitors, we are consistently experiencing 3 failure situations: 1.Failure to acquire a signal from the sensor within a reasonable time frame at the beginning of a case 2.Complete loss of signal during a case 3.Erroneous desaturation signal during a case to date no significant patient harm has occurred; however we are most concerned about the potential for patient harm through misdiagnosis or mistreatment due to unreliable equipment.Multiple events have occurred over the last 6 months with this equipment and this type of scenario.Manufacturers of devices were notified and have come on-site to observe and work with staff/equipment.
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manufacturer response for masimo disposable peds oximetry sensor, masimo (per site reporter).
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provided engineering and clinical support, new equipment, training, data support/ manufacturer has continued to work with us to resolve issues.
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manufacturer response for ge pdm and b850 monitor, carescape monitor series (per site reporter).
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received equipment, engineering support, data collection, on-site clinical and engineering support.Have been working with manufacturer since problems identified.

Event Description

When we use the peds disposable masimo oximetry sensors in conjunction with the ge pdm (patient data module) and b850 monitors, we are consistently experiencing 3 failure situations: 1.Failure to acquire a signal from the sensor within a reasonable time frame at the beginning of a case.2.Complete loss of signal during a case.3.Erroneous desaturation signal during a case.To date no significant patient harm has occurred; however we are most concerned about the potential for patient harm through misdiagnosis or mistreatment due to unreliable equipment.Multiple events have occurred over the last 6 months with this equipment and this type of scenario.Manufacturers of devices were notified and have come on-site to observe and work with staff/equipment.
=
manufacturer response for masimo disposable peds oximetry sensor, masimo (per site reporter).
=
provided engineering and clinical support, new equipment, training, data support/ manufacturer has continued to work with us to resolve issues.
=
manufacturer response for ge pdm and b850 monitor, carescape monitor series (per site reporter).
=
received equipment, engineering support, data collection, on-site clinical and engineering support.Have been working with manufacturer since problems identified.

• Brand Name: MASIMO DISPOSABLE PEDS OXIMETRY SENSOR
• Type of Device: OXIMETRY SENSOR
• Manufacturer (Section D): MASIMO CORP; 52 discovery; irvine CA 92618
• MDR Report Key: 4823622
• MDR Text Key: 21056261
• Report Number: 4823622
• Device Sequence Number: 2
• Product Code: DQA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 2329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2015
• Patient Sequence Number: 1
• Treatment: UNKNOWN: HAVE BEEN EVALUATING POTENTIAL; ENVIRONMENT IN USE AT SAME TIME.; INTERACTIONS WITH OTHER EQUIPMENT AND PHYSICAL