MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SKIN IQ

Model Number SIQPSST04UC

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the nurse on (b)(6) 2014: on an unk date while performing routine pt care, the caregiver noticed that the small blower motor had become very hot.The caregiver removed the skin iq and set it aside for later pick up for arjohuntleigh.There was no injury associated with this event.Due to an abundance of caution, arjohuntleigh is reporting this incident as if this were to recur, it may cause or contribute to a serious injury.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please note that the previous medwatch reports for this product may have been submitted from the manufacturing site (b)(4).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Physical examination/testing: the coverlet was received at arjohuntleigh innovation ctr on (b)(4) 2014.The coverlet was scheduled for examination on (b)(4) 2014.To simulate the alleged complaint sustaining engineering performed the following: the coverlet was placed over a mattress.The fan/pump was connected to a power supply (p/n 4103882) which was plugged in to an 115v source.After several mins, the fan assembly became hot, confirming the alleged complaint.Fan/pump was removed from its enclosure.The fan's wiring configuration was compared to drawing part no: 408012 - rev a (assy, fan, therapy unit).Per the drawing schematic, the fan (p/n 4103838) contains a red wire and black wire.The dc power jack connector (p/n 4103831) has three terminals.The red wire coming from the fan is to be connected to terminal 1 of the dc power jack connector.The black wire coming from the fan is to be connected to terminal 2 of the dc power jack connector.However, on this fan, the red wire was connected to terminal 2 and the black wire was connected to terminal 1 on the dc power jack connector.This resulted in reverse polarity, causing the fan to overheat when power is supplied.The following was observed: fan -no damage was observed.Law tag: manufacturing date: 12/09/2013.Trend code: device failure occurred related.The fan/pump was found assembled incorrectly.Conclusion: the coverlet was received at arjohuntleigh, and then examined by sustaining engineering.To simulate the alleged complaint the fan/pump was powered up and the coverlet did exhibit overheating.The source of the overheating was due to a misassembled fan/pump.The allegation that the coverlet overheated was confirmed and duplicated by sustaining engineering.If this type of malfunction were to recur, it may cause or contribute to serious injury or death.Therefore, this event is reportable.

• Brand Name: SKIN IQ
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4071533
• MDR Text Key: 21731231
• Report Number: 3010048749-2014-00079
• Device Sequence Number: 1
• Product Code: FMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIQPSST04UC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1