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

Model Number	4002-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.
Event or Problem Description
The customer reported room 12 in the picu because the spo2 was ¿bouncing¿ around.I observed spo2 fluctuating from 88% to 93% to 92% to 96% all within about 20 seconds.This is a (b)(6) weighing kg.Neo sensor was on right big toe and detector on nailbed.Rn repositioned sensor correctly on right toe and numbers still fluctuating.An infant sensor was then placed on left big toe, correctly aligned and positioned and spo2 still fluctuating.Rn did not believe it was physiological and grabbed an lnop sensor and cable and placed on lnop infant sensor on pt.¿s left big toe.The lnop sensor still had the variability, but did not go below 90%.The rn placed rd infant sensor on pt.S right big toe and we were able to see, in real time, that spo2 values with both sensors varied, but the rd sensor fluctuated down to 87% -88% while the lnop sensor didn¿t go below 90%.We then switched sensors to see if there was site bias and the rd sensor continued to read down to 87-88% while the lnop did not.No patient impact or consequences reported.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6445645
• Report Number: 2031172-2017-00383
• Device Sequence Number: 1577263
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: (01)10843997009581(17)200101(10)17A03
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4002-9
• Device Catalogue Number: 4002
• Device Lot Number: 17A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 MO
• Patient Weight: 8