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

Model Number ALR04

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); Reaction (2414)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received by arjohuntleigh alpha relief pump was involved in the event due to broken power cable with wires out of isolation.When a facility staff member tried to unplug the power cable to connect the unit to the other outlet, he has received an electric current and as a result lost sensitivity at the finger.No adverse consequences for patient were noticed, no serious injury to the patient or user has occurred.When reviewing similar reportable events, we have found two records presenting a similar scenario as claimed in this complaint - broken electrical components left in use.The occurrence rate observed for this failure mode is currently considered to be very low.It has been established that alpha relief pump was in use for about 9 years, despite the service lifetime covering the period of 7 years.The cable malfunction which led to an adverse event with the involvement of the caregiver was caused by the damaged power cord - internal wires out of isolation.The malfunction was most possibly a result of a part worn during years of usage caused by reduced durability (the power cable was in use for about 9 years).The instruction for use (ifu) for alpha relief ((b)(4)): clearly states the warnings and rules of device maintenance in terms of electrical equipment: "switch off the electrical supply to the pump and disconnect the power cord from the mains supply before cleaning and inspection." "electrical equipment may be hazardous if misused." as mains lead is a critical component of the pump, it should be carefully inspected upon a regular basis.In case of any situation which could potentially affect the cable integrity (cable entrapment, smashing, severing by hard surfaces or sharp objects) the device should be immediately withdrawn from use and repaired.In summary, basing on the information available, it was found that the event was most likely caused by use error - not following the instruction for use.A damage of mains lead was not detected in a timely manner and the cable was left in use, resulting in an adverse outcome for user due to the lack of regular device inspection and improper maintenance procedure.Arjohuntleigh strongly recommends to withdraw the device from use until the pump is repaired and fully functional in order to prevent from the recurrence of similar events.Arjohuntleigh also 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.Although no serious injury took place, we are reporting this event to competent authorities in abundance of caution, due to the probability of harm with a high severity.It is unknown whether alpha relief system was in use for a patient therapy at the time of the event but it was established that contributed to the outcome of the event.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 14 nov 2016 arjohuntleigh has received an information about an incident which occurred on (b)(6) 2016 in the hospital (b)(6) with the involvement of alpha relief system.It was reported that the user, who noticed that the mattress was deflating, tried to unplug the pump cable to check another outlet and he received an electric current at his left hand (left pinkie) due to wires being out of isolation.As a result he lost sensitivity at the finger.This injury was not assessed as serious, no pain or wound were noticed.No injuries to any patient occurred.During the first attempt to repair the unit, arjohuntleigh did not receive any indication from the facility regarding an adverse outcome resulting from pump failure malfunction.The service was performed accordingly, by the replacement of parts.No photographic evidence of the claimed issue was provided.During the service, mains lead, front casing and label were replaced and the pump could come back to use.Besides of cable malfunction also the casing was damaged internally, at the part of pressure controller.

• Brand Name: ALPHA RELIEF
• 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: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6175169
• MDR Text Key: 62541536
• Report Number: 3007420694-2016-00251
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016,11/14/2016

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: Other
• Device Model Number: ALR04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Distributor Facility Aware Date: 11/14/2016
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2007
• 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