MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number 3577

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

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 providing low readings and the plastic guard has broken off.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.During visual inspection, the bend relief sleeve was found to be damaged and the latch is missing.The device passed functional testing and the module maintains communication and measurement with cable bending.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit had no product performance issues related to spo2 and pulse rate.The device functions as designed regarding accuracy and measurements.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.

Event Description

The customer reported the device is providing low readings and the plastic guard has broken off.No patient impact or consequences were reported.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11096515
• MDR Text Key: 224533365
• Report Number: 3011353843-2020-00214
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997007481
• UDI-Public: 00843997007481
• Combination Product (y/n): N
• PMA/PMN Number: K121914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3577
• Device Catalogue Number: 3577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1