MAUDE Adverse Event Report: MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE; OXIMETER

Model Number	3412
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for 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 observed discrepancies up to 12 points (less) than the saturation (masimo) detected by philips monitors.(same settings).They have also tried to swap the application sites (inverting philips monitor with fabian hfoi ventilator) but the problem persists.Since on fabian hfoi ventilator the monitoring of the patient's fio2 (with prico's control is automatic) is bound to the masimo monitoring, we would need to understand exactly the cause of this discrepancy in order to prevent situations where patient is at risk, and in case there was a recall (as you had anticipated by phone) i would need to have more details in order to be able to communicate to acutronic and prevent further deliveries of faulty masimo cables.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.(serial #) updated from "(b)(4)" to "(b)(4)".

• Brand Name: USPO2 PULSE OXIMETRY CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6769555
• Report Number: 2031172-2017-00768
• Device Sequence Number: 16497008
• Product Code: DQA
• UDI-Device Identifier: 00843997007252
• UDI-Public: 00843997007252
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 3412
• Device Catalogue Number: 9476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1