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

Model Number PXB001DAR

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

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

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 arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Arjo was informed about a patient fall from a bed when laying on the auto logic mattress.There was no health consequences to the patient as a result of this incident.To establish circumstances of the alleged incident, the arjo representative contacted with the initial reporter.It was established that the sequence of the events is unknown as the patient was alone in the room.The patient was found on the floor and was confused at the time of the event.At time of the investigation, it was established that despite that the hospital issued recommendations specifying to put the side rails in high position when an air mattress is used, the side rails were in lower position at time of event.Placement of the safety side rails could have prevented the patient fall.Non-arjo medical bed was used.In conclusion, the arjo auto logic system (both mattress and pump) was used while the event occurred, therefore it played role in the event.There was no allegation of arjo device malfunction.Although performed investigation showed that incident was no arjo device related, we decided to report to competent authority due to initial allegation of patient fall.

Event Description

Arjo was informed about a patient fall from a bed when laying on the auto logic mattress.There was no health consequences to the patient as a result of this incident.To establish circumstances of the alleged incident, the arjo representative contacted with the initial reporter.It was established that the sequence of the events is unknown as the patient was alone in the room.The patient was found on the floor and was confused at the time of the event.

• 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: 9791819
• MDR Text Key: 240810030
• Report Number: 3005619970-2020-00003
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2020

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: No Information
• Device Model Number: PXB001DAR
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/05/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 90