MAUDE Adverse Event Report: USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number	3449
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 low readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.Visual inspection found the cable covers were damaged.The module failed functional testing, doesn't power on and was unable to obtain measurements when the uspo2 cable was connected to a power source.X-ray imaging showed damages to the cable near the ch connector that prevents it from powering on and obtaining measurement.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 low readings.No consequences or impact to patient were reported.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Common Device Name: OXIMETER
• MDR Report Key: 12455360
• Report Number: 3011353843-2021-00230
• Device Sequence Number: 19814493
• Product Code: DQA
• UDI-Device Identifier: 00843997011433
• UDI-Public: 00843997011433
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 3449
• Device Catalogue Number: 3449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2018
• 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