MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320; MEC

Model Number CM320

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon results of the investigation.

Event Description

On (b)(4) getinge became aware of an incident caused by one of the medical devices manufactured by getinge.From information provided by the customer after the washing process the wash cart from cm320 washer disinfector had been transferred on the unloading conveyor and moved to the clean side.The wash cart during the proper operation should stopped when reached end of the unloader.However in the case reported by the customer the wash cart overturned and fell down to the ground.Service technician who arrived on site reported that stop pin was broken.As a result of the event no injury has been reported.However we decided to report this case in abundance of caution.

Manufacturer Narrative

(b)(4).The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

This report is being filed under exemption e2016015 by the manufacturer (b)(4).The event is still being investigated by manufacturing site and currently the issue is consulted with the supplier.Additional information will be provided following the conclusion of the investigation.

• Brand Name: CM320
• Type of Device: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6743450
• MDR Text Key: 81139404
• Report Number: 9616031-2017-00026
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 07/25/2017,03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CM320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Distributor Facility Aware Date: 06/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other