MAUDE Adverse Event Report: RAINBOW DCI; OXIMETER

Model Number	2696
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the sensor was inaccurate.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported that the sensor was inaccurate.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed.  .

• Brand Name: RAINBOW DCI
• Common Device Name: OXIMETER
• MDR Report Key: 12374737
• Report Number: 3011353843-2021-00221
• Device Sequence Number: 19127597
• Product Code: DQA
• UDI-Device Identifier: 00843997004855
• UDI-Public: 00843997004855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 2696
• Device Catalogue Number: 2696
• Device Lot Number: 20ECY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1