MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ALPHA RESPONSE

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Other  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).We have been informed by the customer that during the night, the mattress "over inflated" causing his legs to slide off the mattress and get caught in side rails.Although there were no injuries reported based on the severity of harm accessed in the risk management document, we decided to report the complaint in abundance of caution.After the incident the arjohuntleigh representative attend the facility to perform a device complex evaluation.The device was assessed by a field technician to be in excellent condition.The comprehensive test performed did not reveal any problem with the device.And attempts to replicate the described issue was not possible.Moreover in accordance to the additional information the device was installed correctly on the bed frame (device name unk) with a use of the straps.Furthermore we are not aware of the original patient position on the mattress, we also have no information regarding patient mobility and state of health prior to the event, which also may have contributed to become entrapped.We have assessed the risk of patient movement on our alternating surfaces and can confirm that there is negligible risk of movement over a prolonged period.In conclusion, it is difficult to address the root cause of this issue based on the information supplied to us, however as there was a suggestion of the potential for injury, therefore we have reported this event to the authorities in abundance of caution.Our pms (post market surveillance) data suggests that this is not a common occurence with this device with no deaths reported.We will continue tio monitor this type of event and should any additional information become available, we will re-open our investigation into the root cause.Finally, the device has not failed to meet its specification, was being used at the time of the event, however no patient injury were reported.

• Brand Name: ALPHA RESPONSE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wet more; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3952412
• MDR Text Key: 4607283
• Report Number: 3007420694-2014-00071
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Remedial Action: Inspection
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1