MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW DCI-MINI SC-1000; OXIMETER

Model Number	3799
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the device provided higher than expected readings.They had to contact donor to administrate fe and special food to compensate the injury (blood extraction).No serious patient consequences reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.The sensor life has expired all of the allotted spot check measurements have been used.External visual inspection showed no damage.The sensor passed continuity testing, no short or open was detected and no intermittent short or open was detected when the sensor is manipulated.Accuracy testing could not be performed as the sensor life has expired.When connected to a monitor a "please replace sensor" error is displayed which is consistent with a sensor with no additional spot check measurements remaining.Brand name updated from rainbow dci-mini sc-200 to rainbow dci-mini sc-1000.Model # updated from 3797 to 3799.Catalog # updated from 3797 to 3799.
Event or Problem Description
The customer reported the device provided higher than expected readings.They had to contact donor to administrate and special food to compensate the injury (blood extraction).No serious patient consequences reported.

• Brand Name: RAINBOW DCI-MINI SC-1000
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8220295
• Report Number: 2031172-2019-00004
• Device Sequence Number: 11180009
• Product Code: DQA
• UDI-Device Identifier: 00843997008976
• UDI-Public: 00843997008976
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3799
• Device Catalogue Number: 3799
• Device Lot Number: 17AD5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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: Other