MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRMEDSURG

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Please refer to importer report #: (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for kinair medsurge and kinair medpulse devices, we have not been able to find any similar fault description compared to the situation investigated here: noisy work of the device.There is no trend observed for reportable complaints with this failure.In the complaint at hand, the pt did not have any adverse consequences as a result of being on the bed or due to the noise (that the original complaint was submitted for).The pt died of natural causes and his death was unrelated to the arjohuntleigh's product, the alleged device malfunction was not a contributory factor in the pt's death- the pt just happened to be on the bed when he died.An inspection check conducted after collecting the system (after end of rental period) did not reveal any failures or anomalies within the system, the claimed malfunction was not confirmed or found.It seems that the most likely possibility is that the issue with the noisy functioning of the device was related to the blowers (one being redundant) - the system switches between blowers every time power is cycled.If the one blower is noisy the issue would self-correct when the power is cycled.At this point there is no indication that the device caused a pt death.In summary, the device was being used, when the noisy functioning of the device occurred, and therefore the malfunction occurred during pt treatment.It could be interpreted that the device contributed to the event since the pt was lying on the device, however we could not found any indication that the device actively caused or contributed to the pt's death, it was merely present.There is no indication that claimed noisy functioning of the device cause or contribute to this outcome.The cause of the death could not be related to the use nor malfunction of the device.We only report this in the abundance of caution and to be transparent.Given the circumstances and no past similar events, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout dr.; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4336978
• MDR Text Key: 5219020
• Report Number: 3007420694-2014-00136
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,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: 06/17/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1