MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-08-11 for PARKER BATH AL11110-CA manufactured by Arjohuntleigh Polska Sp. Zo.o..
[25488722]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for parker bath, we have found a number of other cases w/similar fault description - "door fell down". We have been able to establish that there is decreasing complaint trend concerning these kinds of events. Pls note that arjohuntleigh manufactured over (b)(4) parker baths to date. With the amount of sold devices and w/comparison to the daily use of them, the occurrence rate observed for complaints w/this failure mode in the last 5 yrs. , is considered to be low and acceptable. The device was inspected by an arjohuntleigh rep at the customer site and found to be out of the specification; defective and worn gas strut. The device was being used for patient handling and in that way contributed to the event. Product instruction for use (ifu) is provided w/each device. Ifu: 04. Al. 00/3 gb from november 2005, informs: "the normal useful life of this equipment, unless otherwise stated, is ten years, subject to required preventative maintenance as specified in this manual. Preventive maintenance schedule (pms), is included in product ifu. The equipment is a subject for wear and tear and the maintenance instructions must be performed when specified to ensure that the equipment remains within its' original mfr's specification. This includes: check of door lock and operation by a caregiver every week and replacement of door gas strut by a qualified personnel every 3rd yr. The received info showed: the strut had never been replaced, bath was in use for about 9 years, bath wasn't under arjo's service contract for about 6 years after the manufacturing date, around year 2012, the customer signed service contract w/ arjo, last maintenance was performed in november 2014, the gas strut was examined then and found to be "intact". Bath was sold in (b)(6) 2012 and installed in (b)(6) 2012, bath has been regularly serviced since (b)(6). 2012. Pls note that taking into consideration date of re-installation of a bath and start of service contract by arjohuntleigh, gas strut replacement should be scheduled around (b)(6) 2015, and the date of the reported event is (b)(6) 2015. Within this time, the involved bath wads checked and served in regular basis, this includes door operation and gas strut. The arjohuntleigh service and checks started from the assumption that the device was correctly maintained against its' labeling, up until the point where arjohuntleigh started doing service. In accordance to above info, we conclude that this incident was caused by user error; lack of maintenance before service contract w/arjo: gas strut wasn't replaced as recommended by the manufacturer. This conclusion is in line w/other similar complaints rec'd to date. The rec'd info showed also that the involved staff was aware about not correctly functioning door. : "the caregiver mentioned she felt the door felt heavy, but since no one had reported any issue prior she went ahead and gave the bath". The user did not mitigate risk by putting the device out of the service. The received info and our evaluation as described above are showing that if parker's maintenance procedures were followed in accordance to instruction of use, there would be no patient or caregiver at risk. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25488723]
Initially it was reported by the arjohuntleigh's representative that parker's bath door fell onto caregiver during use: "information from the site is that the door fell on her back while she was giving a resident a bath, she had the door open and the tub in the upright position, and the door fell on her back while she was bent over in the tub undoing the sling. " the injured caregiver advised to see the doctor for check-up only. No other medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2015-00154 |
| MDR Report Key | 4999550 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-07-20 |
| Date Facility Aware | 2015-07-20 |
| Report Date | 2015-08-11 |
| Date Reported to FDA | 2015-08-11 |
| Date Reported to Mfgr | 2015-08-11 |
| Date Mfgr Received | 2015-07-20 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2015-08-13 |
| 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 | 1265 WETMORE STE. 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 KOMORNIKI |
| Manufacturer City | POZNAN 62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARKER BATH |
| Product Code | ILM |
| Date Received | 2015-08-11 |
| Model Number | AL11110-CA |
| Device Availability | Y |
| 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 POZNAN 62052 PL 62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-11 |