MAUDE Adverse Event Report: COROMETRICS MEDICAL SYSTEMS, INC. COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER

Model Number FFCM3205

Device Problems Break (1069); Calibration Problem (2890); Material Integrity Problem (2978); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete; however, initial visual inspection identified that the case was cracked.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

Reportedly, post repair, the device was not working.It is unknown if there was patient involvement.There was no patient harm.No additional information is available.

Manufacturer Narrative

The complaint device was returned.Device evaluation identified an internal short in the cable and a cracked case.The toco transducer bottom case cover, us transducer large screw covers, us transducer small screw cover, and toco cable assembly were replaced.The parameter tests were performed and all passed.A definitive root cause for the internal cable short and case damage cannot be determined.This type of event will continue to be monitored.Subsequent to the initial mdr, additional review of the hhe-2019-01 and hhe-2019-02 assessments have been conducted.The health care professional has concluded all fetal transducer products in relation to the resulted recall for both hhe's provided, do not qualify as reportable incidences; therefore, this malfunction should not have been submitted.

• Brand Name: COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): COROMETRICS MEDICAL SYSTEMS, INC.; 61 barnes park rd. north; wallingford CT 06492
• MDR Report Key: 9253203
• MDR Text Key: 177823014
• Report Number: 3007409280-2019-00070
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K982651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FFCM3205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1