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

Model Number	4002
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring 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 a (b)(6), female, non-invasively ventilated patient who normally runs 80-85% o2 saturations was displaying an o2 saturation of 65% with 3-stars, yet the patient looked physiologically stable.The patient had an rd set inf-l sensor on the (l) great toe.Debbie and stephanie followed troubleshooting tips, put on a new inf-l sensor and repositioned to the (r) great toe.The patient still had an o2 saturation of 65-69% with 3 stars on the ge monitor.It was decided by the nurses to put the patient on an lnop neo-l sensor on the (l) great toe.There was an 8% point difference once the lnop neo- l sensor was plugged in to the ge carescape bx50 monitor, with the lnop sensor reading 72%.Further troubleshooting with the rd set inf-l sensor improved slightly, but still at a 5-6% difference with 3-stars, with the lnop sensor reading higher.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: 6445805
• Report Number: 2031172-2017-00387
• Device Sequence Number: 1200301
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4002
• Device Catalogue Number: 4002
• Device Lot Number: 17A03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• 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
• Patient Age: 7 MO
• Patient Weight: 5