MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-08-14 for SKIN IQ SIQPSST04UC manufactured by Arjohuntleigh Inc..
[21731231]
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.
Patient Sequence No: 1, Text Type: D, B5
[22090907]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010048749-2014-00079 |
| MDR Report Key | 4071533 |
| Report Source | 05,07 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-24 |
| Date Mfgr Received | 2014-07-24 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJOHUNTLEIGH INC. |
| Manufacturer Street | 12625 WETMORE RD STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN IQ |
| Product Code | FMW |
| Date Received | 2014-08-14 |
| Returned To Mfg | 2014-08-04 |
| Model Number | SIQPSST04UC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH INC. |
| Manufacturer Address | 12625 WETMORE RD STE 308 SAN ANTONIO TX 78247 US 78247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-14 |