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

Model Number 4050

Device Problems Incorrect Measurement (1383); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2017

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

The customer reported an interruption of patient monitoring and an extended period of time before the spo2 begins to read.Per the customer, when it does begin to read, it starts very low and then takes an extended time to come up to the expected spo2.The spo2 will then randomly drop-out again with the same behavior as start-up.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.No external physical damage was observed.The sensor failed continuity testing due to multiple broken traces inside the rd15 connector causing multiple open connections.The sensor was connected to a monitor and was unable to obtain readings, the sensor led did not illuminate., corrected data: model # was corrected from 4085-9 to 4050, lot# was corrected from 16jvg to e16jps, catalog # was corrected from 4085 to 4050, udi# corrected from (b)(4) to (b)(4).Corrected from k051212 to k042536.Corrected from 09/09/2016 to 09/01/2016.Corrected from a blank field to rd set ge-12.

• Brand Name: RD SET DCI
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6341919
• MDR Text Key: 67816166
• Report Number: 2031172-2017-00231
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997009805
• UDI-Public: (01)00843997009805(11)160901(10)16JVG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• 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
• Device Operator: Health Professional
• Device Model Number: 4050
• Device Catalogue Number: 4050
• Device Lot Number: E16JPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1