MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB CAIRWAVE / RENAISSANCE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Following the information reported, a nurse received electrical current from a cairwave pump due to ripped out power socket, when making an attempt to push it back into the pump.A damaged socket was found during a relocation of the bed.The assembly was found damaged and not secured with a cable clamp.No injuries to any patient result from this event.The nurse went to accident & emergency department for electrocardiography examination.No burning marks or any other serious outcome sustained, she felt a pain in her arm.The lady did not use a sick leave after the incident- no hospitalization was required, she came back to work, although, complained about a pain in her shoulder.This was followed by another visit at a&e department after 2 days, however, no further treatment was applied.According to an opinion of arjohuntleigh clinical expert, this injury was not assessed as serious.When reviewing similar reportable events on cairwave system, we have found no other case presenting a similar scenario as claimed in this complaint.The occurrence rate observed for this failure mode is currently considered to be very low.Following the information gathered, a nurse noticed the malfunction (hanging mains socket) when trying to relocate the bed.It is highly possible that socket was ripped out due to an accidental and strong pull of the electrical cable, which did not result in a disconnection between the cable and power inlet, but caused the whole socket to be ripped, leaving an active power supply connection.The act of ripping may have occurred either before or during the bed relocation.The problem was detected, however the reaction of involved staff was not appropriate - the nurse tried to adjust the socket without disconnecting the unit from a power supply.The socket got into a direct contact with nurse's hand.The cairwave operating and product care instructions (document id lft4623) clearly state: - "ensure the mains (power supply) cable is not trapped or twisted and is routed suitably to avoid crushing or entrapment when connected to the product." (general safety rules) - "when connecting equipment after transportation or storage, inspect the mains (power supply) cable visually for any signs of damage." possible sequence of events presented above seems to be the most probable and in line with the event description.It was found that the event was most likely caused by use error - not following the ifu guidelines and warnings.Arjohuntleigh suggests to remind the staff involved of the device labeling, with a special attention paid towards a careful device handling and maintenance.This is to be communicated to the customer.Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no serious injury occurred, there was a probability of harm with a high severity.It has been established that the cairwave system was not used for patient therapy at the time of the event but contributed to the outcome of the event for caregiver.Based on the above, the pump was found to have malfunctioned (not performing up to the specification) when the event took place.

Event Description

On (b)(4) 2016 arjohuntleigh received an information about an incident occurred with cairwave pump.It was reported that a nurse has received an electric current from a ripped out pump socket.It was indicated that the nurse was moving the bed when she noticed that the black connection on the side of the cairwave pump unit was hanging out.While she attempted to the part back into the pump she received an electric current.Power cord was not damaged.No injuries to any patient resulted from this event.The nurse went to accident & emergency department for electrocardiography examination.No burning marks or any other serious outcome sustained, she felt a pain in her arm.The lady did not use a sick leave after the incident- no hospitalization was required.

• Brand Name: CAIRWAVE / RENAISSANCE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 16645444
• MDR Report Key: 6198499
• MDR Text Key: 63663914
• Report Number: 3007420694-2016-00243
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2016,11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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: 12/22/2016
• Distributor Facility Aware Date: 11/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2016
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/22/2016
• 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