MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5V PULSE OXIMETER

Model Number	25199
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional 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., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported the device is missing an led segment.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.During inspection, the unit was found to have an led segment on the upper digit display which did not illuminate.Alarm alert conditions with audible and visual status indicators were found to be functional.Internal inspection was unable to isolate the failure to a component.All led segments were found to be fully functional; the system board likely had borderline faulty led.As a secondary failure, cracks were found in the device's housing.A service history record review reveals that this unit was in the field for over one (1) year with no previous issues related to this reported event.(b)(6).

• Brand Name: RAD-5V PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8034060
• Report Number: 2031172-2018-00529
• Device Sequence Number: 1584900
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: 25199
• Device Catalogue Number: 9197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1