MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number 78400-402

Device Problems Fumes or Vapors (2529); Ventilation Problem in Device Environment (3027)

Patient Problems Respiratory Distress (2045); Patient Problem/Medical Problem (2688)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

An operator of medivators dsd edge automated endoscope reprocessor reported to be experiencing respiratory issues (constant coughing, runny nose) since working with rapicide pa high level disinfectant beginning in 2013.She states that she continues to experience these symptoms and has sought additional medical attention from a doctor and is being prescribed medication for the reported respiratory issues.No information was provided regarding if the operator has predisposing medical conditions that may be contributing to the reported respiratory issues.It is unknown if the reprocessing room is equipped with proper ventilation and the required minimum air exchanges per medivators customer requirements pre-installation instructions.Due to other employees at the facility noting that the room has bad ventilation, the room's ventilation system is being investigated internally by the facility.No information was made available regarding the results of this investigation.Medivators field service staff and clinical specialist have been made aware of this complaint, however the facility no longer has a service agreement with medivators and therefore an fse has not visited the facility recently.The initial reporter was informed by medivators ra that a medivators fse could be dispatched upon request by the facility to evaluate the machine if desired.The facility has not requested the machine to be evaluated by medivators as they are doing the investigation internally.Medivators will continue monitoring this complaint within the medivators complaint system.

Event Description

An employee from a facility reported experiencing respiratory issues while operating the dsd edge automated endoscope reprocessor with rapicide pa high level disinfectant.The facility is investigating the ventilation system of the room as the possible cause of the reported respiratory issues.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6821400
• MDR Text Key: 83672935
• Report Number: 2150060-2017-00037
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: 78400-402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other