MAUDE Adverse Event Report: EMMA (MMHG) CAPNOGRAPH KIT; OXIMETER

Model Number 18265

Device Problem Sensing Intermittently (1558)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted., (b)(6).

Event Description

The customer reported the device works intermittently, does not recognize when adapter is moved.No patient impact or consequences were reported.

Manufacturer Narrative

Other, other text: the returned device was investigated.Visual inspection found the detector lens is recessed.The unit powered on and off using battery power but the device triggers a clogged adapter error when the airway adapter is installed.A red error light flashes on the display when this error is present.The clogged adapter error is due to the recessed detector lens.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.Initial reporter phone number exceeded the maximum allowable characters, phone number is as follows: (b)(6).

Event Description

The customer reported the device works intermittently, does not recognize when adapter is moved.No patient impact or consequences were reported.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Type of Device: OXIMETER
• MDR Report Key: 12492447
• MDR Text Key: 272174848
• Report Number: 3011353843-2021-00245
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 07350046131750
• UDI-Public: 07350046131750
• Combination Product (y/n): N
• PMA/PMN Number: K063167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 18265
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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