MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET ADT; OXIMETER

Model Number 4000

Device Problem No Audible Alarm (1019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

Attempts for the return of the product as well as additional information requests have been made in order to identify the product involved in the reported event.The customer indicated that the product used for this event was discarded and the lot/serial number was not available.If new information is obtained, a follow-up report will be submitted.

Event Description

The customer reported: ¿patient came back from the operating room and was placed on the pulse ox.While hooking up the rest of the monitors the nurse realized the patient's saturation was 55% and that he was respiratory obstructed.The monitor did not alarm nor did it flash or blink.They had to do jaw thrust maneuvers and place a nasal airway in the patient.Saturation eventually came up to 70% then gradually higher, but monitor never alarmed".Customer also stated that it was a good pleth waveform and they believed the numbers, but did not save the sensor as they did not feel that it was a sensor issue, but rather an alarm set-up issue.

• Brand Name: RD SET ADT
• 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: 6696125
• MDR Text Key: 79348106
• Report Number: 2031172-2017-00701
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• 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: 07/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention