MAUDE Adverse Event Report: MEDIVATORS CER-2R; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number CER-2R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2014

Event Type  No Answer Provided  

Event Description

Prefilter assembly on a cer-2r automated endoscope reprocessor failed and flooded the facility.Patient procedures delayed.

Manufacturer Narrative

Facility was flooded due to pre-filtration assembly failure.Medivators field service engineer reported to the scene and discovered that the water source connected to the reprocessor was not shut off overnight.A filter canister had cracked due to over-tightening by facility personnel.Building was shutdown.The fse reported that the extent of the flooding was severe.All offices, hallways, and procedure rooms had several inches of water on the floor causing extensive damage to the sheet rock.There are no reports of injury or illness to patients or personnel as a result of this incident.The water on the floor was not dirty or contaminated.Procedures reportedly delayed/cancelled for a few weeks while facility repair took place.Fse repaired filtration system and the device now operates according to specifications.

• Brand Name: CER-2R
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 3725042
• MDR Text Key: 4327462
• Report Number: 2150060-2014-00009
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CER-2R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2009
• 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