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

Model Number 3577

Device Problems Incorrect Measurement (1383); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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 cable is coming apart at the sleeve, leaving a gap with visible wire and is giving inaccurate o2 readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.During evaluation the device passed all functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.No product performance issue related to spo2 and pulse rate was identified.The device had a damaged stress relief, but it was not found to impact functionality.A service history record review reveals that this unit was in the field for over nine (9) months with no previous reported issues prior to this reported event.

Event Description

The customer reported the cable is coming apart at the sleeve, leaving a gap with visible wire and is giving inaccurate o2 readings.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: 9630164
• MDR Text Key: 179249433
• Report Number: 3011353843-2020-00004
• 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: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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: 01/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1