MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 REGIONAL OXIMETER MODULE

Model Number 24667

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

It was reported that "o3 modules found with heat damage to the sensor connections." no consequences or impact to patient were reported.

Manufacturer Narrative

The returned module was evaluated.Visual inspection found signs of damage that is consistent with the module subjected to drops and sensors connected backwards.The module was connected to a root and successfully established communication.  during testing the module was able to obtain measurements continuously with a known good sensor.The customer complaint not duplicated.The module is fully functional.  a service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.

Event Description

It was reported that "o3 modules found with heat damage to the sensor connections." no consequences or impact to patient were reported.

• Brand Name: O3 REGIONAL OXIMETER MODULE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977168
• MDR Report Key: 8539885
• MDR Text Key: 142762750
• Report Number: 2031172-2019-00213
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

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
• Device Operator: Health Professional
• Device Model Number: 24667
• Device Catalogue Number: 9637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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