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

Model Number	4002-9
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.(b)(6).
Event or Problem Description
The customer reported the sensor provided inaccurate lower reading.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.Visual inspection upon receiving revealed no external damage or defects.The sensor passed continuity tests; no short or open connection was detected.The sensor passed the functional test and was able to obtain spo2 (96%) and pulse rate (75 bpm) values.The sensor also passed the spo2 simulation tests.The sensor is functioning as designed.(b)(6).Corrected data: d4 model # was updated from 4002 to 4002-9.
Event or Problem Description
The customer reported the sensor provided inaccurate lower reading.No patient impact or consequences were reported.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8558251
• Report Number: 2031172-2019-00222
• Device Sequence Number: 19384899
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: 10843997009581
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2019

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: 12/01/2021
• Device Model Number: 4002-9
• Device Catalogue Number: 4002
• Device Lot Number: 18N70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: RAD-97