MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW R1 25L; OXIMETER

Model Number 2414

Device Problem Incorrect Measurement (1383)

Patient Problems Cyanosis (1798); No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

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.

Event Description

The customer reported that the device provided inaccurate spmet measurements."the case involves a wisdom tooth extraction on a (b)(6) girl with type 2 congenital methemoglobinemia.I placed a rev n sensor on the right ring finger and the spmet reading was 0.0.After it didn¿t change i placed another sensor on the left thumb.The spmet stayed 0.0.The patient was also cyanotic with blue fingertips and cheeks.Our spo2 read 11% on room air at the beginning of the case which improved to 35% with 2lpm o2 by nasal cannula.On induction and intubation they placed a left radial arterial line.Po2 on 35% was above 100 and spo2 remained 40%.Met level read 13.9, though it was out of range for their co-ox so they only told us.They drew 2 more abgs that was consistent on the met level.We placed o3 on the patient as well which stayed around 49-51 throughout the case." no known impact or consequence to patient were reported.

Manufacturer Narrative

The returned sensor was evaluated.During evaluation the sensor passed all visual and continuity testing.No errors or interruptions to measurements were observed and no loss of measurements with cable bending.The sensor was functioning as designed.

Event Description

The customer reported that the device provided inaccurate spmet measurements."the case involves a wisdom tooth extraction on a 16 year old girl with type 2 congenital methemoglobinemia.I placed a rev n sensor on the right ring finger and the spmet reading was 0.0.After it didn¿t change i placed another sensor on the left thumb.The spmet stayed 0.0.The patient was also cyanotic with blue fingertips and cheeks.Our spo2 read 11% on room air at the beginning of the case which improved to 35% with 2lpm o2 by nasal cannula.On induction and intubation they placed a left radial arterial line.Po2 on 35% was above 100 and spo2 remained 40%.Met level read 13.9, though it was out of range for their co-ox so they only told us.They drew 2 more abgs that was consistent on the met level.We placed o3 on the patient as well which stayed around 49-51 throughout the case." no known impact or consequence to patient were reported.

• Brand Name: RAINBOW R1 25L
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8417958
• MDR Text Key: 138901731
• Report Number: 2031172-2019-00124
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997002322
• UDI-Public: 10843997002322
• Combination Product (y/n): N
• PMA/PMN Number: K081659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 2414
• Device Catalogue Number: 2414
• Device Lot Number: 18EDX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR