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

Model Number	4002-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2017
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 a batch of rd set inf and rd set neo probes rejected because have seen spectral deviation of -4% (at 70% saturation) in several probes.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The customer returned forty (40) sensors: thirty-six (36) unopened (still sealed in original manufacturer packaging) and four (4) opened; the opened sensors were evaluated.During evaluation the sensors passed all visual and functional testing.The sensors were determined to be functioning as designed.(b)(6).Model # corrected from 4002 to 4002-9.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7148124
• Report Number: 2031172-2017-01106
• Device Sequence Number: 1109099
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: 10843997009581
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 07/01/2020
• Device Model Number: 4002-9
• Device Catalogue Number: 4002
• Device Lot Number: 17GGJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/03/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1