MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-87 HORIZONTAL; OXIMETER

Model Number 22742

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

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.

Event Description

The customer reported that this device once powered on, will shut off if any pressure is applied to the top of the case.No consequences or impact to patient were reported.

Manufacturer Narrative

Upon receiving a visual inspection revealed no external damage.The device was to power on using ac power, but not dc power.Pressure applied to the top of the shell caused the device to power off, as reported.The device was able to obtain readings and did alarm with audible and visual status indicators when thresholds were breached.Internal inspection indicated the system circuit board's dc to dc converter (u28) was damaged; causing an intermittent connection responsible for the device shut-down when pressure was applied to the top of the shell.Additionally, the battery was found to be unable to hold a charge.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.

• Brand Name: RAD-87 HORIZONTAL
• 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: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 7061045
• MDR Text Key: 93531893
• Report Number: 2031172-2017-01038
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22742
• Device Catalogue Number: 9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• 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