MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-5 PULSE OXIMETER

Model Number 22330

Device Problem Sensing Intermittently (1558)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported the cable receptacle is intermittent.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.During functionality testing, the unit powered on and off using battery power but a sensor was unable to connect to the device to take measurements.The mini d 20 connector of the instrument board was damaged.The device cannot take measurements due to bent sensor connector not allowing a proper connection.A service history record review reveals that this unit was in the field for over eight (8) years with no previous reported issues related to this reported event.

Event Description

The customer reported the cable receptacle is intermittent.No patient impact or consequences were reported.

• Brand Name: RAD-5 PULSE 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12840889
• MDR Text Key: 281437296
• Report Number: 3019388613-2021-00325
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22330
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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