MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER

Model Number 22042

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

The customer reported saturation was off.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.

Event Description

The customer reported saturation was off.No patient impact or consequences were reported.

• Brand Name: RAD-8, HORIZONTAL
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10692042
• MDR Text Key: 211885799
• Report Number: 3011353843-2020-00167
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: 00843997005647
• Combination Product (y/n): N
• PMA/PMN Number: K053269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: Lay User/Patient
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1