MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY KIT, RADIUS-7; OXIMETER

Model Number	24949
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported the device loses connection with board.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.Visual inspection found no external damage or defects.The unit powered on and off using battery power and also while docked.The device would not connect to a known good instrument module.During log file analysis, the fault retrieval logs indicate several occurrences of a "sysfault 52" (software fault).Internal inspection found contamination on the battery board u7 component.The battery board was directly connected to a known good instrument module, communication was successful and the module was able to pair with a root.Good continuity was measured across the back cover pogo pins.Potential poor connection between the battery board and back cover pogo pins, results in the unit to become unable to communicate with a known good instrument module.The battery board u7 component is contaminated, can potentially cause a "sysfault 52" error to occur.The unit will not be able to connect to a known good instrument module or root when this error occurs.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event., corrected data: correction to h4: model # from "9664" to "24949" and h4: catalog # from "24949" to "9664".
Event or Problem Description
The customer reported the device loses connection with board.No patient impact or consequences were reported.

• Brand Name: KIT, RADIUS-7
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11641171
• Report Number: 3011353843-2021-00084
• Device Sequence Number: 3071555
• Product Code: DQA
• UDI-Device Identifier: 00843997009249
• UDI-Public: 00843997009249
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 24949
• Device Catalogue Number: 9664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1