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

Model Number 27803

Device Problem High Readings (2459)

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

Event Date 07/23/2021

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.

Event Description

The customer reported that the emma provided high values.No consequences or impact to patient were reported.

Event Description

The customer reported that the emma provided high values.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated and passed functional testing.During accuracy testing, the unit measured outside of the specification.A zeroing calibration was performed and the following measured value was within accuracy specification.Incorrect zeroing results in co2 measurements outside the accuracy specification.Performing zeroing restored accuracy.A service history record review reveals that this unit was in the field for over eleven (11) months with no previous reported issues related to this reported event.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Type of Device: OXIMETER
• MDR Report Key: 12328315
• MDR Text Key: 266870599
• Report Number: 3011353843-2021-00201
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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: 27803
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• 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
• Patient Age: 33 YR