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 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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 for very long, and does not provide good readings.No patient impact, or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.The device was able to power on using both ac and battery power.When powered on the unit could obtain readings and alarmed audibly and visually under alarm conditions.The device passed both manual and preset measurement tests for spo2 and pulse rate.No issues related to measurement accuracy were identified.The battery would only power the device for three (3) hours prior to shutting down with a low battery alarm.The customer's complaint regarding readings was not confirmed however the device battery did not hold a charge for the required length of time.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event.

Event Description

The customer reported the device is not holding a charge for very long and does not provide good readings.No patient impact or consequences were reported.

• Brand Name: RAD-8, HORIZONTAL
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10692107
• MDR Text Key: 211904635
• Report Number: 3011353843-2020-00169
• Device Sequence Number: 1
• Product Code: DQA
• 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: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1