MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET GE - 12; OXIMETER

Model Number	4085
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
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.
Event or Problem Description
The customer reported they are experiencing intermittent spo2 dropouts and readings.No patient impact or consequences have been reported.
Event or Problem Description
The customer reported they are experiencing intermittent spo2 dropouts and readings.No patient impact or consequences have been reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed a cut on the outer jacket along the length of the cable.The cable failed continuity testing as multiple conductors were cut in two which caused multiple open connections.When connected to a monitor and sensor readings could not be provided.

• Brand Name: RD SET GE - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10644904
• Report Number: 3011353843-2020-00153
• Device Sequence Number: 14178432
• Product Code: DQA
• UDI-Device Identifier: 00843997009805
• UDI-Public: 00843997009805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 4085
• Device Catalogue Number: 4085
• Device Lot Number: 19HFK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1