MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5XBC0CON4880A

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2017 arjohuntleigh was notified by (b)(6) hospital in (b)(6) about an incident involving enterprise 5000x bed.Following information provided the bed collapsed with patient lying on the bed.In the consequence of the incident no injury was sustained.It needs to be emphasized that all manufactured enterprise 5000x beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found therefore the manufacturing error can be ruled out.After the incident the device was inspected by arjohuntleigh representative.The evaluation revealed that the bed collapsed as the radius arm detached from the sub-frame.What is more, it has been noticed that backrest frame, control box and urine bag rail were deformed.Additionally backrest actuator's cover was damaged.The above mentioned malfunctions the most likely occurred after bed's collapse, as a consequence of radius arm detachment.According to the nurse the patient lying on the bed at the time of the malfunction was diagnosed with cognitive impairment with behavioral and psychological symptoms of dementia (bpsd) likely underlying vascular dementia.The patient was restrained on the bed and behave in very aggressive way which caused the base frame to dislodge.It is worth noting that the enterprise 5000x bed has been designed, produced and certified to meet the requirements of standard en (b)(4).This confirms that the beds are stable devices which are not falling apart during usage accordingly to product instruction for use.Based on the information collected above we conclude that the device involved in the event was a subject to abuse and enormous external forces what i consequences led to the incident.The comprehensive analysis of previous complaints confirms this statement.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the bed's collapse while being in use with patient.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine that the aggressive way of using our device contributed to the incident.The device was reported to collapse and from that perspective, the enterprise 5000x bed did not meet its manufacturer's specification.

Event Description

On (b)(6) 2017 arjohuntleigh was notified about an incident involving enterprise 5000x bed.Following information provided and photographic evidences the radius arm became dislodged from the sub frame while patient was lying on the bed.According to the staff nurse the patient in question was diagnosed with cognitive impairment with behavioral and psychological symptoms of dementia (bpsd) likely underlying vascular dementia.The patient was restrained on the bed and behave in very aggressive way which caused the base frame to dislodge.The patient did not suffer any injuries due to the incident.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7166979
• MDR Text Key: 96841557
• Report Number: 3007420694-2018-00006
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/05/2018

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
• Device Model Number: E5XBC0CON4880A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2018
• Distributor Facility Aware Date: 12/15/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2018
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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