MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL-7; OXIMETER

Model Number 9500

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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.(b)(6).

Event Description

It was reported: no audible alarm although the received value of spo2 was under low level and its color changed in red.Medical engineer confirmed both cases.The audible alarm sometimes sounded and no audible alarm.The sensor was lncs inf(pn:1861).Alarm setting: spo2 max:off, low level :95%, pr max:170,low level:70, alarm delay:0, alarm mute: 1 minutes.Patient information: male, (b)(6), spinal muscular atrophy(sma) with artificial respiration.Complaint history: on (b)(6): the patient started staying in the hospital with our product radical-7()sn:(b)(4)).On (b)(6): the patient's mother told the hospital staff that the alarm sound was delayed in radical-7.The alarm was set in 0 sec at that time.In line with this, the m.E.Confirmed the issue of no audible alarm and audible alarm properly with the sensor worn the patient.On (b)(6): the same issue happened and so the hospital staff replaced another radical-7.On (b)(6): the patient mother told the hospital staff that the same issue happened.In line with this, the hospital staff replaced rad-8.On (b)(6): there was no problem with this rad-8.However, the patient's mother said that the default setting was so complicated.And then the hospital staff exchanged rad-8 from other device (nellcore).On (b)(6): our sales rep visited the hospital to confirm the issue, but the issue was not duplicated.No consequences or impact to patient.

• Brand Name: RADICAL-7
• 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6464100
• MDR Text Key: 72333488
• Report Number: 2031172-2017-00422
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9500
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• 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
• Treatment: RDS-1
• Patient Age: 32 MO