MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-87; OXIMETER

Model Number 21649

Device Problem No Audible Alarm (1019)

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

Event Date 05/02/2017

Event Type  malfunction  

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.

Event Description

It was reported that device "does not alarm when the battery is about to die".Per the customer, the unit failed to alarm and did not provide an error message or alarm before it turned off.No known impact or consequence to patient was reported.

• Brand Name: RAD-87
• 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: gail hapner ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6583350
• MDR Text Key: 75719852
• Report Number: 2031172-2017-00589
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005609
• UDI-Public: 00843997005609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21649
• Device Catalogue Number: 9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2009
• 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