MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET NEOPT; OXIMETER

Model Number	4004-9
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.No physical damage was observed.The sensor passed continuity tests, no short or open connection was detected and no intermittent short or open connection was detected when sensor was manipulated.The sensor was able to obtain spo2 (96%) and pulse rate (75 bpm) values within normal expected time frame (within 10 seconds).The sensor was functioning as designed.(b)(6).
Event or Problem Description
The customer reported the rd newborn sensor is not giving accurate values.Philips x3 sp05 (rd newborn sensor): had first value: 70%, last value: 85%.Philips x2 fast (fast pediatric adhesive sensor): first value 80%, last value 95%.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.No physical damage was observed.The sensor passed continuity tests, no short or open connection was detected and no intermittent short or open connection was detected when sensor was manipulated.The sensor was able to obtain spo2 (96%) and pulse rate (75 bpm) values within normal expected time frame (within 10 seconds).The sensor was functioning as designed.(b)(6).Brand name was corrected from rd set newborn to rd set neopt.Model # was corrected from 4013-9 to 4004-9.Catalog # was corrected from 4013 to 4004.Lot # was corrected from 17eqh to 17nbv.Expiration date was corrected from 05/01/2020 to 12/01/2020.Udi was corrected from (b)(4).Date received by mfr was corrected from 01/03/2019 to 03/19/2019.Device mfr date was corrected from 05/15/2017 to 12/07/2017.
Event or Problem Description
The customer reported the rd newborn sensor is not giving accurate values.Philips x3 sp05 (rd newborn sensor): had first value: 70%, last value: 85%.Philips x2 fast (fast pediatric adhesive sensor): first value 80%, last value 95%.No patient impact or consequences were reported.

• Brand Name: RD SET NEOPT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8279445
• Report Number: 2031172-2019-00018
• Device Sequence Number: 1370671
• Product Code: DQA
• UDI-Device Identifier: 10843997009659
• UDI-Public: 10843997009659
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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 Expiration Date: 12/01/2020
• Device Model Number: 4004-9
• Device Catalogue Number: 4004
• Device Lot Number: 17NBV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RD RAINBOW SET R25-12 PC