MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH

Model Number AL27010-EU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/11/2015

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

(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).

Manufacturer Narrative

(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.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4808000
• MDR Text Key: 16459664
• Report Number: 3007420694-2015-00107
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2015,05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AL27010-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Distributor Facility Aware Date: 05/11/2015
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/28/2015
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention