MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-05-29 for PARKER BATH AL27010-EU manufactured by Arjohuntleigh Polska Sp. Z O.o..
[16459664]
Initially it was reported by arjohuntleigh representative that "the door had opened too quickly and hit a carer in the head/face causing an injury that required stitches". An arjohuntleigh engineer attended site and fully assessed the door operation. The door opening mechanism is assisted by a gas strut and spring which also prevents the door from closing while in use. All mechanisms and door fixings were inspected and found to be working correctly. There is no adjustment possible to the gas strut or spring. These were found to be working as per manufacturer's instructions. There was no force rating visible on the gas strut.
Patient Sequence No: 1, Text Type: D, B5
[16764318]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). As of 2014 that number was de activated due to the site no longer shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports. Additional information will be provided following the conclusion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37129240]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for parker bath, we haven't found any other cases with similar fault description - door caused an injury during it being opened. We find this complaint to be a single event. The device was being used for the patient handling and in that way contributed to this event. The exact root cause for this complaint remains unknown. Despite our many attempts we were not able to obtain additional information regarding details of this incident since the injured caregiver was out of the work due to sick leave and it was not possible to interview her. The facility where the event occurred was also not able to specify the reported situation due to insufficient information left by the staff member. Please note that during device examination by the arjohuntleigh engineer no malfunction was found with the device. Bath was working in accordance to its specification and was out back into use: "all mechanisms and door fixings were inspected and found to be working correctly. There is no adjustment possible to the gas strut or spring. These were found to be working as per manufacturer's instructions". The instruction for use (ifu) is provided with each device. Ifu informs about correct and safe use of a device, including door operation: "to unlock the door: press the door handle down until aligned with the sticker showing an open lock" "open the bath tub door by pressing the door handle down. Make sure no objects are in the path of opening the door. Raise the door to a fully open position" the only possibility for the head/face injury as initially reported by the customer is the situation where the user keeps the head right above the door while opening what constitute to user error and not following ifu's recommendation as presented above.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00107 |
| MDR Report Key | 4808000 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-05-11 |
| Date Facility Aware | 2015-05-11 |
| Report Date | 2015-11-18 |
| Date Reported to FDA | 2015-11-18 |
| Date Reported to Mfgr | 2015-05-28 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-06-02 |
| 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 PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Product Code | ILM |
| Date Received | 2015-05-29 |
| Model Number | AL27010-EU |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-29 |