MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL-7 HANDHELD; OXIMETER

Model Number 23786

Device Problems Failure to Charge (1085); Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

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 does not charge and that it detects saturation unreliably.No patient impact or consequences were reported.

Event Description

The customer reported the device does not charge and that it detects saturation unreliably.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the returned device was evaluated.External visual inspection showed that pogo pins 7,9,10 and 11 were stuck.The device did not turn on using battery.When using ac power the device powered on, the battery charging led would intermittently flash and power off, the device did not sync with the rds.The battery was replaced and the unit was able to power on using battery power.The customer's battery was placed in a known good device and was able to charge.The customer's device was able to obtain readings and alarmed audibly and visually under alarm conditions.Measurement accuracy testing was performed and no issues were identified.The customer complaint was not duplicated for measurement inaccuracy, the customer complaint was duplicated for the battery not charging.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.

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8364549
• MDR Text Key: 137052214
• Report Number: 2031172-2019-00093
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23786
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1