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 2016-07-29 for PARKER BATH manufactured by Arjohuntleigh Polska Sp. Z O.o..
[50818288]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[50818289]
It was initialy reported to arjohunteigh representative that: "door is heavy to close and tub leaking from drain. Found door strut worn not supporting door fully. Replaced door strut. No patient involved, no risk or injury reported. "
Patient Sequence No: 1, Text Type: D, B5
[55337445]
An investigation was carried out into this complaint. When reviewing similar reportable events for parker bath we have found a low number of other similar cases - gas strut was unable to support the door. There is no information if the device was being used for the patient therapy. The gas strut was unable to support the door - in that way it contributed to the event. It is not clear when the malfunction has been found due to fact that caregivers were from a 3rd party company. It is unknown which caregiver discovered this problem and in what circumstances. Information gathered during our investigation confirms that the latest replacement of the gas strut on the device at hand has been performed on (b)(6) 2014. Unfortunately the faulty part is not available for return for further examination. The age of the device is significant when this kind of the malfunction occurs. Looking at the date of the production of this device, it was manufactured in 2001 and has already passed its operational lifetime as identified in the device labelling a 5 years ago. All devices are equipped with instruction for use which clearly inform that: "always keep fingers clear of the door when closing". "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventive maintenance as specified in this manual". Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no injury occurred, there was a possibility of harm. From all of above information we could not determine the exact root cause of the failure. It cannot be established if the bath was being used for patient handling but it appears that the device was not according to specification when the event occurred. It appears to have played a role in the event due to having been long outside of its intended lifetime - which is considered to be use error. Despite our best efforts the part was not available for return, we could not test it and establish exact root cause of the problem. Arjohuntleigh suggests to remind the facility that the device passed its operational lifetime and it should be replaced. This is to be communicated to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00160 |
| MDR Report Key | 5833041 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-07-06 |
| Date Facility Aware | 2016-07-06 |
| Report Date | 2016-08-31 |
| Date Reported to FDA | 2016-08-31 |
| Date Reported to Mfgr | 2016-07-29 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2016-07-29 |
| 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 | MRS 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. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-07-29 |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-29 |