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 2018-07-09 for PARKER BATH AL14010-US manufactured by Arjo Hospital Equipment Ab.
[113905094]
(b)(4). The review of similar reportable events with the involvement of the parker bath in last years revealed a low number of complaints related to the situation where the defective door gas strut contributed to an event occurrence. The malfunction was detected during servicing of the device by arjo representative. As a correction, the worn gas strut was replaced. According to arjo technician opinion, the faulty gas strut had low resistance. The faulty part was disposed after the repair. The previous bathtub preventive maintenance was performed by arjo representative in (b)(6) 2017. This device was also repaired in (b)(6) 2018, when the drainage hose was replaced because of the damage. According to the service summary no malfunction of the door gas strut was indicated in both cases. In conclusion, the review of service history for the bathtub did not show any replacements of the gas strut in the past. The parker bath is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification. List of recommended steps can be found in product preventive maintenance schedule active at the time when this device was manufactured (pm0684_01 dated on december 2002). In order to ensure the efficiency and functionality of the door strut, this particular component should be checked every 12 months according the following instruction: "open the door and check that the gas strut holds the door in the upright position and does not drop. " it informs also that the door strut should be replaced after 48 months/4 years of functioning. Please note that operating and daily maintenance instructions (ifu, 04. Al. 00/1 dated on june 2003) delivered with the device, include information which each user of the arjo equipment should follow. In connection with the subject of this investigation, the following warnings were established to prevent from any injury occurrence (p. 4): "always ensure that the equipment is handled by trained staff. " "always ensure that the bathers limbs are clear of the door before closing. " "always keep fingers clear of the door when closing. " the preventive maintenance schedule also reminds the customer to check the operation of the door regularly on a weekly basis to detect any failure related to this assembly: "open and close the door and check the lock and supporting gas strut for correct and smooth operation. " following the collected information it can be determined that the preventive maintenance of the involved unit was not correctly performed. Therefore the most likely root cause for this case is related to maintenance deficiencies. At the time of event the device did not meet manufacturer specification due to worn door gas strut. This however did not cause or contribute to adverse event. According to the collected information the bathtub was used for patient hygiene prior to malfunction detection. We report this incident in abundance of caution due to malfunction which could pose a risk for device users.
Patient Sequence No: 1, Text Type: N, H10
[113905095]
Arjo received a customer complaint on parker bath, where it was reported that the tub door was falling (not keeping the upright position) due to worn gas strut. Despite this malfunction, the bathtub was still used by the customer facility. No event was experienced by the device's users, no harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00137 |
| MDR Report Key | 7669162 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-07-09 |
| Date of Report | 2018-07-09 |
| Date Facility Aware | 2018-06-18 |
| Report Date | 2018-07-09 |
| Date Reported to FDA | 2018-07-09 |
| Date Reported to Mfgr | 2018-07-09 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2004-06-28 |
| Date Added to Maude | 2018-07-09 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-07-09 |
| Model Number | AL14010-US |
| Device Availability | Y |
| Device Age | 13 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-09 |