MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5; OXIMETER

Model Number 22330

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.Initial reporter zip code exceeded the maximum number of allowable digits, zip code is as follows: (b)(6).

Event Description

The customer reported no sound from the speaker.There was some water (distilled water) intrusion.On (b)(6) 2017 per email attached customer stated device could not produce audio alarms if parameters were breached.No patient impact or consequences were reported.

Manufacturer Narrative

The returned device was evaluated.The device passed visual inspection, and was able to obtain spo2, pi, and pulse rate readings.During the evaluation the device was found to experience audio issues, and was unable to provide clear audible alarms when parameters are breached.The speaker was found to have failed due to damage to the system circuit board, the mcu u15 chip, and the resistors and capacitors on the audio module.Secondary findings found damage to the mcu of the circuit system board.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event.(b)(6)."the customer reported no sound from the speaker.There was some water (distilled water) intrusion.On (b)(6) 2017 per email attached customer stated device could not produce audio alarms if parameters were breached.-mj no patient impact or consequences were reported." to "the customer reported no sound from the speaker.There was some water (distilled water) intrusion.Customer stated device could not produce audio alarms if parameters were breached.No patient impact or consequences were reported.".

Event Description

The customer reported no sound from the speaker.There was some water (distilled water) intrusion.Customer stated device could not produce audio alarms if parameters were breached.No patient impact or consequences were reported.

• Brand Name: RAD-5
• 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: 6822979
• MDR Text Key: 83747521
• Report Number: 2031172-2017-00826
• 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,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• 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