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

Model Number	4051-9
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer 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 rd sensor is having intermittent dropout/loss of signal.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned sensor was evaluated.Visual inspection upon receiving revealed no external damage or defects.The sensor failed continuity tests due to an exposed solder joint on the white conductor; causing a short between the white conductor and inner shielding at the detector solder joint assembly.As a result, the sensor functioned intermittently.When the intermittent connection was held in normal operation it was able to obtain spo2 and pulse rate values.When the intermittent connection was held in normal operation and then manipulated to "short" (non-functional) condition, the monitoring device went into alarm condition (audibly and visually alarmed), readings zeroed out, pleth went flat, and ¿sensor off patient¿ error message was displayed.
Event or Problem Description
The customer reported the rd sensor is having intermittent dropout/loss of signal.No patient impact or consequences were reported.

• Brand Name: RD SET DCI-P
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10043647
• Report Number: 3011353843-2020-00073
• Device Sequence Number: 16907591
• Product Code: DQA
• UDI-Device Identifier: 00843997009850
• UDI-Public: 00843997009850
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K080238
• 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): 04/19/2020

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: 4051-9
• Device Catalogue Number: 4051
• Device Lot Number: 19GCX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1