MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET M20-12; OXIMETER

Model Number	4257
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2018
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.
Event or Problem Description
The customer reported the cable is getting rigid and provides bad values.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the cable is getting rigid and provides bad values.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: four cables from the same lot were returned relating to this event.The returned cables were evaluated.External visual inspection showed the cables had torn outer jackets at the bend relief area of the rd15 connector.Theses tears are likely due to the cleaning solution used based upon the stiffness/hardness of the outer jackets at the torn area.The cables passed continuity testing and are fully functional when connected to a monitor.Measurement accuracy testing was performed with all of the cables and no issues were identified.

• Brand Name: RD RAINBOW SET M20-12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8220178
• Report Number: 2031172-2019-00001
• Device Sequence Number: 19240136
• Product Code: DQA
• UDI-Device Identifier: 00843997011679
• UDI-Public: 00843997011679
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/12/2018

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 Model Number: 4257
• Device Catalogue Number: 4257
• Device Lot Number: 17FGW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1