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 03/31/2019

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 that "no sound was heart at all" from the device.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated which included functional testing.During this testing, the device did not make the start up sound at power on and no audio was produced when the alarm limits were breached.The unit did provide visual alarms, an internal inspection of the device was conducted and the unit was confirmed to have an open circuit across the speaker cables.There was no sound coming out of the unit, since the speaker had an open circuit.A service history record review reveals that this unit was in the field for over five (5) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported that "no sound was heard at all" from the device.No consequences or impact to patient were reported.

• 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: 8536146
• MDR Text Key: 142638968
• Report Number: 2031172-2019-00211
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 04/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1