MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8; OXIMETER

Model Number 22042

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

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 Description

The customer reported "no audible alarm sound".No consequences or impact to patient was reported.

Manufacturer Narrative

The returned device was evaluated.During evaluation, an "off patient" error message displayed when masimo dci-dc3 sensor or masimo set tester are connected to the device and no measurements was obtainable.Keypad power button and alarm silence button are both functional, but all other keypad buttons did not.Speakers was able to emit tone when device powered on; however, alarms could not be tested due to measurements could not be obtained and the keypad failure prevents accessing alarm menu.Internal inspection revealed, both speakers are functioning as designed and the customer's complaint in regard to "no audible alarm sound" could not be duplicated.The device sensor flex cable was damaged; which caused the device to not able to get measurements.Foreign contaminant inside the keypad resulting in keypad failure.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues prior to this reported event.

• Brand Name: RAD-8
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6683240
• MDR Text Key: 78909803
• Report Number: 2031172-2017-00686
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1