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

Model Number 22338

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

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

The customer reported the unit fails to make any sound.No power-up sound, no pulse tone or no alarm sound.No patient impact or consequences were reported.

Manufacturer Narrative

The returned device was evaluated.During evaluation the unit turned on using battery power.The device was able to obtain measurements, and alarmed visually under alarm conditions; however no tones were emitted from the device during button press, power on, or alarm conditions.Internal inspection indicated a speaker wire had broken off one of the speaker terminals.Additionally, the speaker had failed with an open coil continuity.The speaker wire was reconnected, and the speaker was replaced and the device functioned as designed.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).

• 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 ; 40 parker; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6645927
• MDR Text Key: 77709301
• Report Number: 2031172-2017-00648
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22338
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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