MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL, HANDHELD; OXIMETER

Model Number 1309

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

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: "the device is causing mild electric shocks.Also the casing is damaged as the monitor is not clicking into place in the docking station.Neither the docking station or the monitor will turn on.It is making quiet clicking sounds as well." no patient impact or consequences were reported.

Manufacturer Narrative

The returned device was evaluated.Visual inspection revealed the thumb latch clip was broken and partially missing.Due to the broken latch clip the unit was unable to stay docked in the docking station.The device was able to power on via both battery and ac power.The unit was found to visually and audibly alarm during alarm conditions.The customer reported mild electric shocks.Internal inspection revealed no circuitry damage or loose circuit board interconnections.The device was verified to be dc voltage powered and therefore, presented no risk of ac electrical shock.Initial reporter zip code exceeded the maximum allowable digits, zip code is as follows: (b)(6).A service history record review reveals that this unit was in the field for over fifteen (15) years with no previous reported issues related to this reported event., corrected data: device manufacture date updated from "07/17/2013" to "06/21/2002".

• Brand Name: RADICAL, HANDHELD
• 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: 7240105
• MDR Text Key: 99092099
• Report Number: 2031172-2018-00067
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040214
• 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: 02/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1309
• Device Catalogue Number: 1309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2002
• 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