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

Model Number 630004FR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by (b)(4) complaint handling establishment, and any medwatch reports will be submitted under registration (b)(4).An investigation is ongoing, conclusions will be provided to the follow-up report.

Event Description

Arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product), and an unknown bed.According to information reported by a customer, the patient fell when she was trying to go to the bedroom.The patient was found conscious laying on the floor.A wound on the left eyebrow arch has been reported as outcome of the reported event.It is unknown if a medical intervention was needed.

Manufacturer Narrative

Corrected following data: describe event as it was clarified that the involved bed was no arjo product.Updated model and serial number of the involved pump (initially provided information was related to mattress).Manufacturer narrative: arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product) and an hill rom bed (no arjo product).The patient was found conscious laying on the floor.A wound on the left eyebrow arch was reported as outcome of the reported event.No medical intervention was needed.An investigation was conducted to establish a root cause of the reported issue.According to information reported by a customer, the patient fell when she was trying to go to a bathroom, the safety sides were not used at time of the event.The decision to use side rails is to be decided according to internal facility protocol.According to instruction for use (654900en_01) ¿whilst the patient is unattended, safety sides should be used based on clinical assessment and in line with local policy.¿ to conclude, the arjo auto logic system (both mattress and pump) was used while the event occurred, therefore it played a role in the event.There was no issue with the arjo device.The safety sides were not used at time of the event.The complaint was assessed as reportable due to allegation of patient fall, which may lead to serious health consequences.

Event Description

Arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product) and an hill rom bed (no arjo product).The patient was found conscious laying on the floor.A wound on the left eyebrow arch was reported as outcome of the reported event.No medical intervention was needed.

• 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
• MDR Report Key: 10815050
• MDR Text Key: 215603217
• Report Number: 3005619970-2020-00020
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 630004FR
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other