MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET DCI; OXIMETER

Catalog Number	4050
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: masimo received a medwatch notification on 4/17/24.Communication was established with the masimo representative working with the customer facility to obtain more details and clarify the issue and reported lot number.To date, the lot number provided on the medwatch has not been received by masimo in order to complete an evaluation on the product.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.H3 other text : device not returned.
Event or Problem Description
The customer reported "patient reported she felt shock sensation through her right heel up into her leg.Husband removed sensor probe from her right toe and called for rn.Pt denies any further pain or discomfort.Per rn no visual signs of injury to patient." there was no patient impact or consequence reported.
Event or Problem Description
The customer reported "patient reported she felt shock sensation through her right heel up into her leg.Husband removed sensor probe from her right toe and called for rn.Pt denies any further pain or discomfort.Per rn no visual signs of injury to patient." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
A response was received from the customer on 5/13/24, subsequent to filing the initial mdr, with additional details including the lot number and confirmation of details regarding the return of the sensor.The sensor was initally received on an older record initiated in november 2023.The evaluation confirmed there was no external damage, defect and no exposed wires.The sensor could obtain values on the lab monitor during testing.There were no shocks produced when testing on the technicians finger and the voltage was within the acceptable limits.The sensor functioned as designed.The lot number, udi, date received at factory and device manufacture date which were unknown when the initial report were filed have been included in this report as new information.

• Brand Name: RD SET DCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19293840
• Report Number: 3019388613-2024-00063
• Device Sequence Number: 15651448
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: 00843997009843
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4050
• Device Lot Number: 22F71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female