MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET DBI; OXIMETER

Model Number	4052
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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 the device provided low/inconsistent readings.The reading was also fluctuating, not a stable reading.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was investigated.Visual inspection passed with no physical damage observed.The sensor failed continuity tests using a tester and a damaged eeprom trace was found at the rd15 connector.When the returned sensor was tested with a radical-7 touchscreen device and rd rainbow set md20-05 cable, "no sensor connected" error message was displayed.No audible or visual alarms were provided and the sensor led did not illuminate.An additional sensor of the same lot was returned which passed visual inspection, continuity tests, and functioned as designed., corrected data: e1 (b)(6).
Event or Problem Description
The customer reported the device provided low/inconsistent readings.The reading was also fluctuating, not a stable reading.No patient impact or consequences were reported.

• Brand Name: RD SET DBI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9742302
• Report Number: 3011353843-2020-00024
• Device Sequence Number: 11383515
• Product Code: DQA
• UDI-Device Identifier: 00843997014298
• UDI-Public: 00843997014298
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080238
• 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): 01/31/2020

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: 4052
• Device Catalogue Number: 4052
• Device Lot Number: 19FLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1