MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW RC25-4RA; OXIMETER

Model Number	3375
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.(b)(6).Device not returned.
Event or Problem Description
The customer reported intermittent trace on device (kept losing signal).No patient impact or consequences were reported.
Event or Problem Description
The customer reported intermittent trace on device (kept losing signal).No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned cable was evaluated.Visual inspection upon receiving revealed a broken pin #24 at the round 25 pin connector.The cable failed continuity tests due to the broken pin #24 (blue conductor) at the round 25 pin connector; causing an open connection on the blue conductor.The cable failed functional tests and displayed ¿chk sensor" error message.No audible or visual alarms.Sensor led does not illuminate.(b)(6).

• Brand Name: RAINBOW RC25-4RA
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8384365
• Report Number: 2031172-2019-00108
• Device Sequence Number: 13516172
• Product Code: DQA
• UDI-Device Identifier: 00843997007078
• UDI-Public: 00843997007078
• Combination Product (Y/N): N
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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 Model Number: 3375
• Device Catalogue Number: 3375
• Device Lot Number: 16NQH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1