MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number E5X2HD103BAAAA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

Following information provided, the radius arm detached from the bed's frame and the bed collapsed.There was no mention of a patient being in bed at that time, no injury reported.

Manufacturer Narrative

During inspection of the enterprise 5000x bed at the customer facility, it was noticed that the radius arm dislodged from the bed's frame.The customer left the device for repair without any information what kind of malfunction occurred.There was no injury or other medical consequences reported.The review of post-market surveillance data and investigation regarding the radius arm detachment, carried out at the manufacturer side showed that this malfunction can occur only under two specific circumstances.First, when the bed¿s backrest is blocked by the obstacle e.G.Windowsill (in the position of 45 degrees), then the backrest is moved to the actuator¿s limit and next to the bed foot section is pulled.The second scenario may take place when the obstacle is put between the base frame and the radius arm.Based on the limited information gathered, the exact scenario which led to the radius arm detachment could not be determined.In summary, there was no indication that the enterprise 5000x bed was used with the patient when the malfunction occurred.During the bed¿s evaluation, the detachment of the radius arm was found, therefore it can be stated that the bed did not meet the manufacturer¿s specification.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the radius arm detachment which might lead to the bed collapse during use with a patient.

• Brand Name: ENTERPRISE 5000X
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 9762242
• MDR Text Key: 198758283
• Report Number: 3007420694-2020-00047
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982747431
• UDI-Public: (01)05055982747431(11)180618
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E5X2HD103BAAAA
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other