MAUDE Adverse Event Report: COOPERSURGICAL, INC. CLEARTONE DOPPLER; FOETAL DOPPLER SYSTEM

Model Number	CT250-3
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is being returned for repair.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the unit was visibly smoking, not working properly.No harm reported.No additional information is available.1216677-2024-00017 (b)(4).
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 08/26/2020 under wo (b)(4) and shipped on 09/08/2020.Manufacturing record review: dhr 292527 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on service notes, this unit was at csi on 03/11/2024.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the device was noted to have significant damage including the board.Exposure to heat and impact was determined to be contributing to the complaint condition.The heat source was not confirmed and the unit was returned without the batteries to evaluate them.However, the only source of heat may be due to defective batteries or an external source exposing the device sufficient heat or some combination of the 2 scenarios.The board is not a potential heat source and the back casing of the device confirms sufficient heat exposure to melt the plastic housing.Root cause is attributed to handling error.The unit was not repairable and scrapped out.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No other action is required.

• Brand Name: CLEARTONE DOPPLER
• Common Device Name: FOETAL DOPPLER SYSTEM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19125182
• Report Number: 1216677-2024-00017
• Device Sequence Number: 8360008
• Product Code: KNG
• UDI-Device Identifier: 00888937001594
• UDI-Public: (01)00888937001594
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K024197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: CT250-3
• Device Catalogue Number: CT250-3
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/27/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown