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	Congestive Heart Failure (1783)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the pediatric icu nurse indicated that the rd inf sensor on a patient's foot of a 8 months old 6 kg baby was reading spo2 in the low 70s.The customer used to get numbers in the 80s with an lnop sensor.The rn was adamant that the patient's normal spo2 is around 80-81%.The rn stated that she has taken care of this patient for 8 months and she knows the 80% spo2 ranges are correct.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6405862
• Report Number: 2031172-2017-00341
• Device Sequence Number: 16342989
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care 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: 4002-9
• Device Catalogue Number: 4002-9
• Device Lot Number: 17A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RD SET GE - 12 PATIENT CABLE
• Patient Age: 9 MO
• Patient Weight: 7