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

Model Number 22338

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.(b)(6).

Event Description

The customer reported the rad-5 had no boot sound, no pulse tone, and no alarm tone.No patient impact or consequences were reported.

Event Description

The customer reported the rad-5 had no boot sound, no pulse tone, and no alarm tone.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the returned device was evaluated.During visual inspection, the unit was found to have cracks on the back chassis.The unit was able to power on using batteries, but no sound emanated from the unit.During functional testing the unit was able to obtain readings and alarm alert conditions were functional but generated visual alerts only.Internal inspection isolated the failure to the unit's speaker.The speaker had an open connection.Initial reporter zip code is entered as "00000" to meet the maximum allowable characters.Initial reporter zip code is 612-8141.A service history record review reveals that this unit was in the field for over five (5) years with no previous issues related to this reported event.

• Brand Name: RAD-5 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8308756
• MDR Text Key: 136147707
• Report Number: 2031172-2019-00063
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K033296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: 01/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1