MAUDE Adverse Event Report: GETINGE DISINFECTION AB NINJO; WASHER OF BODY WASTE RECEPTACLES

Model Number FD1600

Device Problem Fluid/Blood Leak (1250)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration number: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).The device will be evaluated to determine a type of the malfunction occured.The investigation is ongoing and further information will be provided in the next report.

Event Description

Arjo was notified about an incident with involvement of ninjo washer.It was reported that the device was leaking and a member of the customer facility's staff has slipped and injured themself.The staff member sustained minor cuts and bruises to knees and hands.Treatment of injuries was applied on site.Wounds were cleaned and covered with sticking plasters.

Manufacturer Narrative

Arjo was notified about an incident with involvement of ninjo washer.It was initially reported that the device at the sluice room was leaking and a member of the customer facility's staff who entered the room has slipped and injured themselves.The staff member sustained minor cuts and bruises to knees and hands.Treatment of injuries was applied on site.The carer¿s wounds were cleaned and covered with sticking plasters.The device was taken out of use and evaluated by the arjo service engineer.After testing the washer several times the engineer noticed that the steam generator was leaking slightly and also the door seal was passing water from the bottom of the left door¿s side.According to the facility¿s accident book it was not specified if the fall occurred in the sluice room or outside of it.The room in which the device was located had an anti-slip floor, but there was not at the corridor by the sluice room.The device has been repaired with new steam generator and door seal.The ninjo flusher should be used in accordance with a user manual.The user manual states that before using the machine it should be checked for safety to use.It was not specified if the device was functioning at the moment the event occurred, but water leakage could have occurred during operation of the device (leaking from steam generator and chamber).The user manual recommends to contact the authorized service personnel in case of any malfunction to bring the device to the manufacturer¿s specification.This incident is an isolated case as no other issue related to ninjo flusher and to the user slipping on the floor wet due to leakage from the device was found upon review.Therefore, the analysed issue is considered not likely to result in an injury occurrence.Water leakage may be noticed by the device¿s user and mitigated with facility¿s safety measures such as appropriate flooring.Based on the performed review, the root cause may be related the device normal wear not noticed before the event occurred.In summary, the inspection of the device confirmed that it was not up to manufacturer¿s specification after the event and the device did not perform as intended.It is unknown if the device was functioning at the time of event, but was leaking on the floor, so in this way played a role in the event.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to indication of a patient fall, which resulted in an injury occurrence.

Manufacturer Narrative

Arjo was notified about an incident with involvement of ninjo washer.It was initially reported that the device at the sluice room was leaking and a member of the customer facility's staff who entered the room has slipped and injured themselves.The staff member sustained minor cuts and bruises to knees and hands.Treatment of injuries was applied on site.The carer¿s wounds were cleaned and covered with sticking plasters.The device was taken out of use and evaluated by the arjo service engineer.After testing the washer several times the engineer noticed that the steam generator was leaking slightly and also the door seal was passing water from the bottom of the left door¿s side.According to the facility¿s accident book it was not specified if the fall occurred in the sluice room or outside of it.The room in which the device was located had an anti-slip floor, but there was not at the corridor by the sluice room.The device has been repaired with new steam generator and door seal.The ninjo flusher should be used in accordance with a user manual.The user manual states that before using the machine it should be checked for safety to use.It was not specified if the device was functioning at the moment the event occurred, but water leakage could have occurred during operation of the device (leaking from steam generator and chamber).The user manual recommends to contact the authorized service personnel in case of any malfunction to bring the device to the manufacturer¿s specification.The ninjo flusher should be used in accordance with a user manual.The user manual states that before using the machine it should be checked for safety to use.It was not specified if the device was functioning at the moment the event occurred, but water leakage could have occurred during operation of the device (leaking from steam generator and chamber).The user manual recommends to contact the authorized service personnel in case of any malfunction to bring the device to the manufacturer¿s specification.In summary, the inspection of the device confirmed that it was not up to manufacturer¿s specification after the event and the device did not perform as intended.It is unknown if the device was functioning at the time of event, but was leaking on the floor, so in this way played a role in the event.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to indication of a patient fall, which resulted in an injury occurrence.

Manufacturer Narrative

The involved device has been evaluated by the arjo representative.After the washer was tested several times, it was noticed that the heat exchange chamber was leaking slightly and also the door seal was passing water from the bottom of the left side of the flusher's door.The device has been taken out of use until repaired.The investigation is on-going and further information will be provided in the next report.

• Brand Name: NINJO
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11, vaxjo kronobergs lan [se-07]; vaxjo 35115 ; SW 35115
• MDR Report Key: 10947772
• MDR Text Key: 258236963
• Report Number: 3007420694-2020-00184
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FD1600
• Device Catalogue Number: FD1600-001
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other