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	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported the display has led segments that do not illuminate and the case is cracked.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was investigated.External visual inspection found the the case is cracked near the sensor connector.The device passed functionality testing and no internal physical defect or damages were observed.The unit was placed in a burn-in oven for 4 hours at 35 degrees celsius and all segments illuminated and the device functions as designed.The customer's complaint about the cracked case was duplicated but the led segments not illuminating was not duplicated.
Event or Problem Description
The customer reported the display has led segments that do not illuminate and the case is cracked.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: 10431498
• Report Number: 3011353843-2020-00135
• Device Sequence Number: 16962355
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1