MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET DC; OXIMETER

Model Number 4050

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2017

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.(b)(6).

Event Description

It was reported that "dci sensors and cables are not working despite clinical troubleshooting.The customer does not see any physical damage to the cables or sensors in most cases; however, they have informed that they will also see that the rd tab will break off very easily when trying to remove the clear clasp.The sensors and cables are either not providing a spo2 value, waveform or are very intermittent and positional." no known impact or consequence to patient was reported.

• Brand Name: RD SET DC
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6610174
• MDR Text Key: 76592035
• Report Number: 2031172-2017-00631
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4050
• Device Catalogue Number: 4050
• Device Lot Number: E16JPR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2016
• 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