MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER

Model Number 27977

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

The customer reported the device reboots with no reason.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring 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.

Event Description

The customer reported the device reboots with no reason.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.Device functionality testing found the device would power on and reboot, or power off.This would mostly occur when it was moved.Internal inspection discovered the lcd metal back plate has come loose and can cause shorting on the circuit board.The loose metal backing frame on the lcd causes the device to power off and can potentially give fault code messages due to shorts on the board.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.

• Brand Name: RAD-G PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 15068241
• MDR Text Key: 301643411
• Report Number: 3019388613-2022-00162
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: 00843997013284
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K201770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

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: 27977
• Device Catalogue Number: 9847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2020
• 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