MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-12-13 for TENOR manufactured by Arjohuntleigh Polska Sp. Zo.o..
[4100922]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11460398]
(b)(4). This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended. Arjohuntleigh received a complaint where it was indicated that during the patient transfer from the bed to the chair the resident slipped out the front of the sling. The patient had a small hematoma on the frontal parietal scalp as a consequence of the event. When reviewing similar reportable events, we have found a number of cases with similar fault description (slip out of sling). The trend observed for reportable complaints with this failure mode is currently considered to be low and stable. It has been established that the lift device (tenor) and the sling was being used for patient handling at the time of the event. During our investigation, we were not able to find a deficiency with the lift (tenor) which could contributed to the event. An on-site inspection by an arjohuntleigh representative showed that the tenor lift involved in the incident has two sling retaining clips missing from hanger bar. This is not likely to impact the performance of the lift when used according to the ifu, but it is another indication that the preventive maintenance schedule as indicated within ifu was not followed. We have been able to state the sling involved was not arjohuntleigh product and should not have been used. Arjohuntleigh does not approve the use of other mfr's products on their equipment. In this case we can determine that the lift (tenor) and the sling which work as a system were found not to have been to specification when the event took place. Our evaluation appears to be in line with a use error having occurred, but does not allow us to perform a specific stimulation with regards to this event. Our assumption is that the event was caused by use error, based on the customer information. In the labeling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgable of the contents fo the labeling. During normal and on-label use, without any malfunction, it is highly unlikely that a person will fall out on the front of the sling. This is shown by the low complaint volume of such issue when compared to daily use of ten of thousands of devices in the market, and by looking at the position of the person in the sling during transfer. In this case the sling used during this incident was reported as being of a competitor mfr. Arjohuntleigh do not approve the use of other mfr's products on their equipment. Therefore the root cause of this event appears to be use errors: not following the instructions for use section where it was indicated that only arjohuntleigh company designed parts, which are designed for the purpose, should be used on equipment and other appliances supplied by arjohuntleigh, to avoid injuries attributable to the use of inadequate parts. When the ifu would have been followed and the sling was checked to be correctly for use with this tilt (tenor), inappropriate sling would have been detected and the event would have been avoided. From this evaluation it is would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents. We find this complaint to be reportable to the competent authorities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2013-00068 |
| MDR Report Key | 3536974 |
| Report Source | 06,07 |
| Date Received | 2013-12-13 |
| Date Mfgr Received | 2013-11-15 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2013-12-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENOR |
| Generic Name | NONE |
| Product Code | JFT |
| Date Received | 2013-12-13 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-13 |