MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTOLOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

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

Patient Problems Fall (1848); Hematoma (1884)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon the investigation conclusion.

Event Description

On 13th march 2018 arjo was informed about an incident which occurred while using auto logic system.The customer reported that a patient fell from an auto logic matress.As a result patient received an hematoma.A scanner showed no sign of damage to the brain.It is unknown what bed frame was used at the time of event.The customer stated that the side rails were not in raised position at the moment of the incident.Additionally, 2 days before, during the medical transmissions, it was noted that the patient was agitated (patient was found in the middle of the bed) and had insomia despite the medical treatment provided.

• Brand Name: AUTOLOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 7395118
• MDR Text Key: 104735537
• Report Number: 3007420694-2018-00079
• 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: 04/04/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2018
• Distributor Facility Aware Date: 03/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2018
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/04/2018
• 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
• Patient Age: 71 YR