MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 9X21AJ001DAABA

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2018 arjohuntleigh was notified about the malfunction incolving enterprise 9000x bed.Following the information provided the electric cpr did not work during patient's intubation.The reset of the bed was performed, the bed worked correctly and then again the cpr function was blocked.There was no injury sustained.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).On 09-jan-2018 arjohuntleigh received a customer complaint involving enterprise 9000x.The reported malfunction took place in the hospital (b)(6).Following information provided the patient placed on the bed was intubated.The electric cpr control button was pressed to enable intubation to be carried out.Despite button activation the cpr function did not work.To restore cpr function the reset of the bed was performed.After the rest the bed started working as intended and then again after a while the functions became blocked.No injury was reported in relation to this incident.The patient was successfully intubated.It needs to be emphasized that each enterprise 9000x bed is equipped with manual cpr release handles located below the calf section on each side of the bed and electric cpr buttons build up in control panels.These features flatten the mattress platform to the horizontal position to enable inter alia intubation to be carried out.Even though the electric cpr does not work the manual cpr can still be used.In this particular case the manual cpr was not activated as the facility staff did not realize they may use it.After the incident the bed was inspected by arjohuntleigh technician with regards to the reported issue.The evaluation revealed that there was no malfunction found within the device.The bed operated as intended and the malfunction could not be recreated.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.The device history record has been reviewed for this specific device and no anomaly was found.Summarizing, upon the conducted investigation we were not able to confirm reported issue (no product malfunction was found within the device during device inspection) therefore we were not in position to determine the exact cause of the reported malfunction.Although there were no injuries reported, the complaint was decided to be reportable due to electric cpr being inoperative in emergency situation.At the time of the incident the bed was being used for patient care and was not working up to manufacturer's specification.

• Brand Name: ENTERPRISE 9000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7250926
• MDR Text Key: 99911187
• Report Number: 3007420694-2018-00041
• Device Sequence Number: 1
• Product Code: FNL
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9X21AJ001DAABA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Distributor Facility Aware Date: 01/09/2018
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 03/09/2018
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other