MAUDE Adverse Event Report: . SKIN IQ 365; BED, FLOTATION THERAPY, POWERED

Model Number SIQCPRUS1UN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjo was informed that a customer staff sustained back injury while repositioning patient in the bed.It was reported that the patient was a quadriplegic with a progressive disease, and continually sliding down in bed.According to a nurse, the patient was sliding down because of the slippery sheet that went with the mattress and the nature of the mattress itself.The customer could not identify the products involved in the event, but upon arjo investigation, we concluded that most likely arjo skin iq 365 (described as sheet by the nurse) was used with non-arjo mattress.

Event Description

Upon further investigation we determinate that arjo citadel patient theraphy was used with integrated air mattress.

Manufacturer Narrative

Additional information: arjo was informed that a customer staff sustained back injury while repositioning the patient in the bed.It was reported that the patient was a quadriplegic with a progressive disease, and continually sliding down in bed.According to a nurse, the patient was sliding down because of the slippery sheet that went with the mattress and the nature of the mattress itself.As a consequence, the nurse was manually repositioning the patient and sustained "significant" back injury.The nurse was out of work for a prolonged period of time.The nurse (directly involved in the event) expressed her opinion that she was informed by the person(s) delivering the bed (to the facility) that no other sheets or things should be used on the mattress.However, the safe patient handling coordinator (from the customer site) confirmed that staff has been trained and aware that safety for themselves and the patients are the primary concern.Although it may be preferred that nothing, else be on the bed, if the situation requires it, the caregiver can put a repositioning sheet on the bed for patient repositioning.The customer could not identify the products involved in the event, but upon arjo investigation, we concluded that most likely arjo skin iq 365 (described as a sheet by the nurse) was used with arjo citadel bed.Please note that the ifu for the skiniq product contains information that: "it is important for users to read the familiarize themselves with these instructions and to consult the treating physician prior to patient placement and product use, individual patient conditions may vary." "patient migration specialty surfaces have different friction and support characteristics that conventional surfaces and may increase the risk of patient movement, skin and/or migration into hazardous positions of entrapment and / or inadvertent bed exit.Monitor patients frequently to guard against entrapment." please note that the technique choose to reposition the patient is under trained personnel responsibility.The information provided by arjo representative that no other sheets or things should be used on the mattress is the only recommendation.Moreover, after the event, the customer provided education for staff that when the similar situation will to reoccur, the caregiver could always contact with arjo representative and ask for a different mattress that would be more suitable for the patient based on her assessment and issues she was experiencing.To conclude, the skiniq was used for the patient's care.There was no malfunction found with the product from that perspective the system meet the manufacturer's specification.We decided to report this event due to the indication that the customer staff sustained a significant back injury.

Manufacturer Narrative

Missing serial number and udi number was added.Also sex was added.

• Brand Name: SKIN IQ 365
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): .; parque industrial itabo; (piisa) bldg 9; haina, san crist?bal,
• MDR Report Key: 8420725
• MDR Text Key: 138813767
• Report Number: 3012292104-2019-00006
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2019

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: Health Professional
• Device Model Number: SIQCPRUS1UN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2019
• Distributor Facility Aware Date: 02/13/2019
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 02/13/2019; 02/13/2019
• Supplement Dates FDA Received: 04/12/2019; 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization