MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY KIT, RAD-97 PULSE CO-OXIMETER

Model Number 27573

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer 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 turned off and will not power on.No patient impact or consequences were reported.

Event Description

The customer reported the device turned off and will not power on.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.The power button led starts blinking when power on is attempted and the device does not power on.The battery was near depletion before the device left the customer.The device will not power on when the battery is depleted and the power button is being pressed while the ac power cord is being connected.The ac power and battery power must be disconnected to clear this condition.The device can power on with a depleted battery if the power cord is connected and the power button is pressed after the ac indication led is illuminated.The device can also power on if the battery is charged to any amount above depletion.Software issue results in device not being able to power on and the led to continuously blink.A service history record review reveals that this unit was in the field for over six (6) months with no previous reported issues related to this reported event.

• Brand Name: KIT, RAD-97 PULSE CO-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: 14527395
• MDR Text Key: 293461978
• Report Number: 3019388613-2022-00124
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997012317
• UDI-Public: 00843997012317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27573
• Device Catalogue Number: 9738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• 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