MAUDE Adverse Event Report: RD RAINBOW SET M20-12; OXIMETER

Model Number	4257
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
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 cable lost signal during use.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported that cable lost signal during use.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.A torn bend relief on the connector side was found during visual inspection.The device passed continuity testing and functional tests.The cable was able to obtain measurements and was functioning electrically as designed.

• Brand Name: RD RAINBOW SET M20-12
• Common Device Name: OXIMETER
• MDR Report Key: 12477960
• Report Number: 3011353843-2021-00240
• Device Sequence Number: 17072270
• Product Code: DQA
• UDI-Device Identifier: 00843997011679
• UDI-Public: 00843997011679
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042536
• 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): 08/23/2021

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: 4257
• Device Catalogue Number: 4257
• Device Lot Number: 20GBE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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