MAUDE Adverse Event Report: MASIMO - 40 PARKER RED LNC-10; OXIMETER

Model Number	2056
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.No physical damage was observed.The cable passed continuity tests, no short or open connection was detected, and no intermittent short or open connection was detected when cable is manipulated.The cable passed spo2 simulation tests and was able to obtain spo2 (96%) and pulse rate (75 bpm) values.The cable was found to be functioning as designed.
Event or Problem Description
The customer reported the spo2 values would begin reading ok then, would suddenly drop into the 60s and 70s.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the spo2 values would begin reading ok then, would suddenly drop into the 60s and 70s.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.No physical damage was observed.The cable passed continuity tests, no short or open connection was detected, and no intermittent short or open connection was detected when cable is manipulated.The cable passed spo2 simulation tests and was able to obtain spo2 (96%) and pulse rate (75 bpm) values.The cable was found to be functioning as designed.Age at time of event was updated to 5 yr.Sex: was updated to male.

• Brand Name: RED LNC-10
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8502169
• Report Number: 2031172-2019-00170
• Device Sequence Number: 16615558
• Product Code: DQA
• UDI-Device Identifier: 00843997001267
• UDI-Public: 00843997001267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• 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): 03/20/2019

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: Lay User/Patient
• Device Model Number: 2056
• Device Catalogue Number: 2056
• Device Lot Number: 18KSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR