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

Model Number 3577

Device Problem Sensing Intermittently (1558)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

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 an intermittent connection.No patient impact or consequences were reported.

Event Description

The customer reported an intermittent connection.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed a damaged ch stress relief and the latch is missing.The device failed functional testing, it does not draw power or communicate with the test fixture when the cable is bent.Discontinuity was measured on the wire when the cable was bent.A service history record review reveals that this unit was in the field for over ten (10) months with no previous reported issues related to this reported event.

• 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: 10898453
• MDR Text Key: 218253348
• Report Number: 3011353843-2020-00189
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 12/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1