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

Model Number ALR01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Electric Shock (2554)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The electric shock sustained resulted in redness and slight numbness in the arm.The nurse went to the emergency room to be checked over.No further details of medical examination were provided the inspection of the pump at the customer¿s facility by arjo representative revealed, that the device was in an overall good condition, except for the power cord fault.The device was taken out of use after the event occurred.The evaluation of the device performed at arjo service center after returning it from the customer confirmed that apart from the power cord failure, the internal pump electrical features remained functional.It was not possible to determine the cause of the malfunction.It is unknown if at the time of the event the device was used for treatment of the patient or not.The power cord detached therefore it failed to meet its specification.This complaint was decided to be reported to the regulatory authorities due to sustained electric shock.

Event Description

Following the information provided, when the nurse pulled up bottom of the pump, the power cord came out of its fitting and touched her arm, leading to a mild shock.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 11656202
• MDR Text Key: 250240379
• Report Number: 3007420694-2021-00055
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALR01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2021
• 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