MAUDE Adverse Event Report: MASIMO - 40 PARKER RAS-45, ACOUSTIC RESPIRATION SENSOR; OXIMETER

Model Number	4171
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.(b)(6).
Event or Problem Description
The customer reported: "0 rra reading at moments, while sometimes they also get no reading (no value on device) at all.".No consequences or impact to patient was reported.

• Brand Name: RAS-45, ACOUSTIC RESPIRATION SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7405761
• Report Number: 2031172-2018-00218
• Device Sequence Number: 11124368
• Product Code: DQA
• UDI-Device Identifier: 10843997009635
• UDI-Public: 10843997009635
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial

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: 08/01/2019
• Device Model Number: 4171
• Device Catalogue Number: 4171
• Device Lot Number: 17G42
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 97