MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY PRONTO SPOT CHECK PULSE CO-OXIMETER

Model Number 25212

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The customer reported the pronto, cable, and sensor were "not providing accurate readings" as the measurements were "off by 2-3 data points" compared to a blood draw.No patient impact or consequences were reported.

Manufacturer Narrative

Other text: the product has been returned to masimo; however the investigation could not be completed at the time of this report.When the investigation is complete a follow up report will be submitted.

Manufacturer Narrative

Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: additionally, the returned cable and sensor were evaluated and passed visual, functional, and sphb simulation testing.No product performance issues related to sphb readings were identified.

Event Description

The customer reported the pronto, cable, and sensor were "not providing accurate readings" as the measurements were "off by 2-3 data points" compared to a blood draw.There was no patient impact or consequence reported.

• Brand Name: PRONTO SPOT CHECK PULSE CO-OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17695722
• MDR Text Key: 322821250
• Report Number: 3019388613-2023-00213
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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
• Treatment: 4059 LNCS-II SPHB SENSOR, 4071 MD20-1.5 CABLE.; 4059 LNCS-II SPHB SENSOR, 4071 MD20-1.5 CABLE.