MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-07-20 for ENTROY GAB1007-01 manufactured by Arjo Hospital Equipment Ab.
[6051883]
Initially it was reported by arjohuntleigh representative that seat partially detached during use. "during the transfer from swimming pool to the wheelchair, the hoist chair was partially broken and the patient fell down in the water and bumped the neck and shoulder. The patient was restrained by the security armband. " the resident sustained head and shoulder trauma, however no hospitalization was required. Only examination was needed, with no medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[14242634]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for entroy we have found a low number of other similar cases, concerning failure of docking mechanism. There is decreasing complaint trend for this issue and no trend for complaint on failure of docking in use with patients. The device was being used for patient handling and in that way contributed to the event. The device examination revealed in finding of malfunction - missing one of springs in locking catch. The rec'd information showed that lack of this part did not affect the device indicator of correct docking and it could only affect handle movement, therefore we don't find this malfunction to be the cause of the reported event. Nevertheless the involved device failed to meet its spec. Please note also that it was not possible to re-create the reported event by the arjohuntleigh service technician. The most likely cause of seat partial detachment is incorrect docking onto lifting arm, which is in line with findings for previous similar complaints. From our eval and the rec'd information, user error cannot be ruled out. See scanned page. No training details were provided for involved staff. From the above we can conclude that the incident was most probably caused by an user error - user didn't followed warnings regarding correct docking and preserving patient's safety. The rec'd information and our eval as described above are showing that if entroy's warnings and transferring procedures would be followed, in accordance to instructions for use, there would be no patient or caregiver at risk. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00140 |
| MDR Report Key | 4932672 |
| Report Source | 06,07 |
| Date Received | 2015-07-20 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-05-27 |
| Date Facility Aware | 2015-06-18 |
| Report Date | 2015-07-17 |
| Date Reported to FDA | 2015-07-17 |
| Date Reported to Mfgr | 2015-07-17 |
| Date Mfgr Received | 2015-06-18 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2015-07-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTROY |
| Product Code | FNG |
| Date Received | 2015-07-20 |
| Model Number | GAB1007-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-20 |