MAUDE Adverse Event Report: GETINGE DISINFECTION AB 91-SERIES; 9128

Model Number 9128

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 we became aware of an incident with one of washers disinfectors- 9128.During the repair of the device, the technician was burned with hot water while attempting to locate the source of the water leak.The burn the technician received was first degree burn.

Manufacturer Narrative

This report is being filed under exemption e2017050 by the manufacturer getinge disinfection ab, (registration no.(b)(4)) on behalf of the importer getinge group logistics america, llc (registration no.(b)(4)).The device, which played role in the investigated herein issue, has been recognized as 91-series washer disinfector with serial number (b)(4) and model number 9128.This gives us the information that it was manufactured on 5th of june 2008 and installed on 10th of july 2008.When reviewing customer product complaints for this type of failures we were able to confirm that, for this model, the issue can be considered as a single and isolated case.Based on all gathered information we were able to establish that during the cycle, water was noticed on the floor and the customer employee wanted to immediately locate the source of the leakage, thus opened the service door while the unit was in the middle of cycle.In that moment, the hose on the drain valve burst and sprayed the employee with hot water.Later on, when the company's representative evaluated the device, he was able to confirm that the hose on the inlet of the drain valve at the drain tank burst.In addition, the pneumatic hose to the drain valve disconnected also and both hoses needed replacement.Having in mind the fact that the device was in use for over 10 years before the issue took place and none of available information indicate previous replacement of those parts, we can conclude that hoses disconnected as an effect of material wear and tear due prolonged time of usage.As per preventive maintenance schedule, the hoses are to be checked yearly and replaced, if necessary.Additionally, to this case it is worth to be noted that the user should not open the service door when the device is in the middle of cycle.As per user manual (doc.Id (b)(4) rev.E) before doing any maintenance work on the machine it must be isolated it from the electric power supply and all tanks must be drained.In summary, upon the issue occurrence the device was not used for patient treatment but it did fail to meet its specifications and due to this played a role in the incident.As a result of the unexpected water leakage under the pressure, the technician sustained a burn of his tight.The injury sustained was not classified as serious one as no medical intervention was required and the technician could get back to work after the assessment.However, having in mind that getting in contact with hot water from the working machine could cause various effects, we decided to report this complaint to competent authorities based on the potential and in abundance of caution.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.The customer has been reminded in regards to safety usage of the device we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: 91-SERIES
• Type of Device: 9128
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• MDR Report Key: 7972844
• MDR Text Key: 123944467
• Report Number: 9616031-2018-00010
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/16/2018,10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9128
• Device Catalogue Number: 9128-002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2018
• Distributor Facility Aware Date: 09/25/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other