MAUDE Adverse Event Report: GETINGE DISINFECTION AB 9100-SERIES; MEC

Model Number 9125

Device Problems Defective Device (2588); Torn Material (3024)

Patient Problem Injury (2348)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 9th february 2017 we became aware of an incident occurred with one of getinge 9100-series washer disinfector.As it was stated by the customer one of the staff member hurt their back while he was removing a cart from the washer.Getinge representative who arrived on site concluded that the wheels for instrument and container rack need to be replaced.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The event is being investigated by the manufacturing site.Root cause of the failure is being established.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Getinge received a complaint where one of the staff members at the customer site hurt their back while removing a wash cart (which is not considered to be a medical device itself) from the 9100-series washer disinfector, which is a medical device.Investigation on this issue was performed.It was found that the wash cart was damaged in a way that would have made removing a difficult and strenuous task.It was not possible to collect more details related to the alleged injuries of the involved person since the customer decided not to provide with further information, citing healthcare privacy laws.When the event occurred the device was not used for treatment or diagnosis.The washer disinfector was up to specification when the event took place.The wash cart (an accessory to the medical device) was not.According to user manual for 9100-series (6001341202, rev.D) washer disinfector; the customer is responsible to check the device is up to specification before use.As stated in the mentioned manual on page 34 it is described that daily check of the device should include checking of the accessories on the machine: "check the accessories of the machine visually with regard to their intended use and function, e.G., blocked ducts, worn and missing parts that might affect the performance of the machine.The water must be able to flow freely through the ducts of tubular instruments.".Moreover the same user manual includes also information about checking proper docking of the wash cart in the case when the washer-disinfector is equipped with optional docking for wash cart: "check that the wash cart docks correctly to the docking unit in the floor." it was established that the root cause of the failure was the tear and wear of the wheels of the wash cart used with the 9100-series washer disinfector.Damaged parts have been replaced after the event, the wash cart was put back in use.We believe that if the customer would follow daily routine described in the user manual of checking the equipment the incident would have been avoided.According to our knowledge it is not likely that the person would receive a serious injury from use of the wash cart with teared wheels, however we report this case in abundance of caution as we were informed about an allegation of the injury.

Manufacturer Narrative

This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).The investigation has been finalized, however the root cause of the issue need to be confirmed.Additional information will be provided upon results of the investigation.

• Brand Name: 9100-SERIES
• 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: 6394484
• MDR Text Key: 69560365
• Report Number: 9616031-2017-00004
• 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,Followup,Followup
• Report Date: 02/09/2017,12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9125
• Device Catalogue Number: 9125-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 02/09/2017
• Supplement Dates FDA Received: 04/11/2017; 05/10/2017; 06/09/2017; 07/11/2017; 11/28/2017; 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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