MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER

Model Number 22042

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

The customer reported the device is not holding a charge or providing good readings.No patient impact or consequences were reported.

Event Description

The customer reported the device is not holding a charge or providing good readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.The device was unable to power on using battery power.The unit powered on and off correctly using ac power and the device turns off immediately if ac power is removed.When powered on the unit was able to obtain readings and alarmed audibly and visually under alarm conditions.Spo2 and pulse rate simulator tests were performed and no issues related to measurement accuracy were identified.Internal inspection found the housing screw mount had broken off.The battery charging circuit output was measured low when connected to ac power.A known good battery was installed and the device was able to power on and off using battery power.The customer's battery was returned to the device and was now able to charge.The customer's complaint regarding readings was not duplicated however the complaint related to not holding a charge was duplicated.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.

• Brand Name: RAD-8, HORIZONTAL
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10692131
• MDR Text Key: 211733713
• Report Number: 3011353843-2020-00168
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: 00843997005647
• Combination Product (y/n): N
• PMA/PMN Number: K053269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: 10/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1