MAUDE Adverse Event Report: COOPERSURGICAL, INC. EHP RFID MODULE

Model Number 5-70-801

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

Event Description

(b)(6) tablet psu static shock.Members of the embryologist team are experiencing static shocks.Testing has been carried out on charging power supply's and surfaces it has been found that all psus are producing a 17 volt ac voltage through the usb this is causing the ehp to statically charge up the plate and is being discharged through the customer when they touch the metal side of the ehp causing them to jump they have informed me that the shock is enough to potentially cause them to drop a dish.I have plugged in my surface psu into all the surface laptops and it works fine normal expected voltage from usb sockets.All power supply units need to be replaced 7 in total.09-12-2020.Ehp rfid module: 5-70-801.E-complaint- (b)(4).

Manufacturer Narrative

Distribution history it could not be determined when the complaint product was manufactured because the lot/serial number of the completed unit was not provided.Manufacturing record review a review of the device history record could not be performed because the lot/serial number of the completed unit was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review 2-year complaint history did show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical as this is a field service complaint.Visual evaluation this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Functional evaluation this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Root cause this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Root cause could not be definitively determined at this time.Correction and/or corrective action the action is to change the tablet power supply and usb hub to an alternative type, surface pro docking station.Subsequent measurements, using the surface pro docking station, indicate that the level of charge is low enough not to be felt by the user.Coopersurgical will continue to monitor this complaint condition for any trends.This complaint was addressed in the field, the technician performed the following: serviced by production team, distributor training issue.Train personnel was the complaint confirmed? yes.

Event Description

Microsoft tablet psu static shock.Members of the embryologist team are experiencing static shocks testing has been carried out on charging power supply's and surfaces it has been found that all psus are producing a 17 volt ac voltage through the usb this is causing the ehp to statically charge up the plate and is being discharged through the customer when they touch the metal side of the ehp causing them to jump they have informed me that the shock is enough to potentially cause them to drop a dish.I have plugged in my surface psu into all the surface laptops and it works fine normal expected voltage from usb sockets.1216677-2021-00085-1 ehp rfid module 5-70-801 e-complaint-(b)(4).

• Brand Name: EHP RFID MODULE
• Type of Device: EHP RFID MODULE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11761874
• MDR Text Key: 261075198
• Report Number: 1216677-2021-00085
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5-70-801
• Device Catalogue Number: 5-70-801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other