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 Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
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 dropped connection when slightly moved.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was investigated.Visual inspection revealed damaged pogo pins on the back of the device.The device powered on with batteries but did not sync with a known good root and the mac address did not change.The device was tested and will not connect to a known good instrument module due to the damaged pogo pin.Internal inspection revealed no defects or damages.The customer complaint was not duplicated.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported dropped connection when slightly moved.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: 9162339
• Report Number: 3011353843-2019-00082
• Device Sequence Number: 1848860
• Product Code: DQA
• UDI-Device Identifier: 00843997009249
• UDI-Public: 00843997009249
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1