MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY 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	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported a segment in the display is missing.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no damage.The device was able to power on under battery power.When powered on all display segments lit up and were stable.The device was able to obtain readings and alarm conditions were audible and visual under alarm conditions.Internal inspection found contamination on the instrument board and keypad flex cable pins.The customer complaint was not duplicated.
Event or Problem Description
The customer reported a segment in the display is missing.No patient impact or consequences were reported.

• Brand Name: RAD-5V PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10248096
• Report Number: 3011353843-2020-00106
• Device Sequence Number: 3093171
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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
• 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: 07/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1