MAUDE Adverse Event Report: MASIMO CORPORATION; OXIMETER

Device Problems False Reading From Device Non-Compliance (1228); High Readings (2459); Low Readings (2460)

Patient Problem No Information (3190)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

The masimo pulse oximetry was giving a wide variety of reading often with good pleth.Both higher 90 readings and low reading were seen, which never correlate with blood gas numbers.The md found this pulse ox's to be highly unreliable.Even after the patient was pronounced dead, the pulse ox kept reading 92% with a descent waveform.Pulse oximeters, which md's have found to be unreliable and give us false low or high readings all the time, are used not only in the medical intensive care unit (micu) but also in pulmonary lab as well.

• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 5161300
• MDR Text Key: 28721286
• Report Number: 5161300
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 67