MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 LARGE SENSOR; OXIMETER

Model Number 3756-9

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the local facility, but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.

Event Description

The customer reported the device provided inaccurate readings when compared to another device.No patient impact or consequences were reported.

Manufacturer Narrative

The returned sensor was evaluated.External visual inspection showed cosmetic damage that does not affect the functionality.The sensor was able to obtain readings, and the readings were consistent with a known good sensor, no issues relating to measurement accuracy were identified.The sensor is fully functional., corrected data: additional information; d4 model # updated from 3756 to 3756-9.

Event Description

The customer reported the device provided inaccurate readings when compared to another device.No patient impact or consequences were reported.

• Brand Name: O3 LARGE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8560774
• MDR Text Key: 143431929
• Report Number: 2031172-2019-00225
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K160526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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 Expiration Date: 12/01/2021
• Device Model Number: 3756-9
• Device Catalogue Number: 3756
• Device Lot Number: 18N92
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1