MAUDE Adverse Event Report: MASIMO - 40 PARKER PRONTO SPOT CHECK PULSE CO-OXIMETER

Model Number 25212

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

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.Device not returned.

Event Description

He customer reported the device provided slow readings, high readings, and no readings at all.No consequences or impact to the patient were reported.

• Brand Name: PRONTO SPOT CHECK PULSE CO-OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977863
• MDR Report Key: 8207235
• MDR Text Key: 131764947
• Report Number: 2031172-2018-00599
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997008921
• UDI-Public: 00843997008921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25212
• Device Catalogue Number: 9167
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1