MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY EMMA KIT; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	3639
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: masimo has reached out to the customer to request the return of the device.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.H3 other text : product not returned.
Event or Problem Description
The customer reported the emma "switches off while resuscitation is in progress." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
The returned emma was evaluated.The device powered off when the shaken due to damaged housing and a loose battery terminal that caused the battery to lose contact with the terminal.
Event or Problem Description
The customer reported the emma "switches off while resuscitation is in progress." there was no patient impact or consequence reported.

• Brand Name: EMMA KIT
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - SWEDEN AB; industrial vallera de mexicali calzada del oro, no.2001; danderyd 18233 ; SW 18233
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 19397582
• Report Number: 3019388613-2024-00074
• Device Sequence Number: 7744230
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: (01)07350046131033(11)161111(21)233427
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3639
• Device Catalogue Number: 3639
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2016
• 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
• Patient Sex: Unknown