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

Model Number 22042

Device Problem No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

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

Customer reported "reads 'sensor off' but doesn't alarm." no known impact or consequence to patient was reported.

Manufacturer Narrative

The returned device was evaluated.During inspection, the unit was unable to power on via battery power.Using ac power, the device was able to obtain readings and alarmed audibly and visually under alarm conditions.The brightness setting key, switch 5, was non responsive on the keypad and showed signs of physical damage.As a result, the alarm functions were inaccessible.Internal inspection showed the battery was disconnected.The customer complaint could not be 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.

• 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: 6565011
• MDR Text Key: 75099136
• Report Number: 2031172-2017-00552
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• 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: 05/12/2017
• 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: 05/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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