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

Model Number 22042

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The device did turn on using ac power.However, the device did not turn on using battery power because the battery was disconnected.Once the battery was reconnected and charged, the device powered on using the battery.The device was able to obtain spo2 and pulse rate readings.The device was found to visually and audibly alarm during alert conditions.Internal visual inspection revealed no defects or damages.Both front and bottom speakers were measured and found to be within the specification.The device was found to be functioning as expected.

Event Description

The customer reported the rad-8 device will not alarm.No patient impact or consequences were reported.

• Brand Name: RAD-8, HORIZONTAL
• 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: 8677056
• MDR Text Key: 147572823
• Report Number: 2031172-2019-00282
• 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: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/17/2019

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: Lay User/Patient
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• 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