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

Model Number 630009AU

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1000381138, 3007420694.Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration #3005619970.Arjo was informed about an event involving auto logic pump.Following information reported to arjo by the customer representative, a nursing staff member suffered an electric shock while moved the pump plugged into the power source.The nurse was checked by the hospital¿s emergency department where it was confirmed that she did not sustain any injury.The arjo representative established that the reported incident occurred when the pump was picked up by the nurse (to connect an aura cushion to the pump).At that time, the pump was shorted out, causing a bang sound, sparks from the pump power cord and burning smell.Following the event, the pump was inspected by the arjo service technician.It was found that the power cord was broken and the outer casing of the pump is damaged.According the opinion of the arjo service technician, possible minor damage of the power cord prior the installation then movement/pulling of the power cord led to cord shorting.To conclude, the complaint was decided to be reportable due to allegation of the electric shock sustained by the nurse.When the event occurred, the device did not meet its performance specifications.Upon the conducted investigation, we were able to determine that damage of the power cable was a contributing factor to the electric shock occurrence.The circumstances in which the damage of the power cord occurred were not established.

Event Description

Arjo was informed about an event involving auto logic pump.Following information reported to arjo by the customer representative, a nursing staff member suffered an electric shock while moved the pump plugged into the power source.The nurse was checked by the hospital¿s emergency department where it was confirmed that she did not sustain any injury.

• Brand Name: AUTO LOGIC
• 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: 10038053
• MDR Text Key: 242606371
• Report Number: 3005619970-2020-00004
• 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: Other
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2020
• 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