MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAINBOW SET PULSE CO-OXIMETRY CABLE, GE CARESCAPE; OXIMETER

Model Number	4184
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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 the measurement is being interrupted.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was investigated.External visual inspection found no damage.During functional testing, the module lost connection to the sensor intermittently and was unable to obtain measurements when the cable was twisted and moved around.An x-ray image showed damage to the cable near the cable connector.The customer complaint was duplicated.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the measurement is being interrupted.No patient impact or consequences were reported.

• Brand Name: RAINBOW SET PULSE CO-OXIMETRY CABLE, GE CARESCAPE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9826245
• Report Number: 3011353843-2020-00033
• Device Sequence Number: 11204199
• Product Code: DQA
• UDI-Device Identifier: 00843997010832
• UDI-Public: 00843997010832
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050252
• 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): 02/19/2020

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: 4184
• Device Catalogue Number: 4184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1