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

Model Number	4051-9
Medical Device Problem Codes	Break (1069); Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
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).
Event or Problem Description
The customer reported sensors and cables not working despite clinical troubleshooting.The customer does not see any physical damage to the cable or sensors in most cases; however, they have indicated that the rd tab will break easily when trying to remove the clasp.These sensors and cables are not providing a spo2 values or waveforms, or are very intermittent and positional.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.Visual inspection showed no external physical damage.The sensor failed continuity testing due to multiple broken traces inside the rd15 connector causing multiple open connections.The broken traces were likely due to mechanical stress from removal of the sensor from the cable based on the appearance of the break.The sensor was connected to a monitor and a "no sensor connected" error message was displayed and the sensor leds do not illuminate.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).Corrected data: model # corrected from 4051 to 4051-9.

• Brand Name: RD SET DCI-P
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6628946
• Report Number: 2031172-2017-00637
• Device Sequence Number: 13639867
• Product Code: DQA
• UDI-Device Identifier: 00843997009850
• UDI-Public: (01)00843997009850(11)170201(10)R17BXK
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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 Model Number: 4051-9
• Device Catalogue Number: 4051
• Device Lot Number: R17BXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 08/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1