MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SHOWER CABIN (PRELUDE); ILS

Model Number BBA1254-04

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

Patient Problem Physical Entrapment (2327)

Event Date 11/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.An investigation was carried out into this complaint.When reviewing similar reportable events for shower cabin (prelude) we haven't found any other similar cases - finger pinched during use.We find this complaint to be a single event.The device was being used for patient handling and in that way contributed to the event.We decided to report this complaint in abundance of caution due to potential risk to the patient if the hazard situation was to re-occur.Operating and product care instructions is provided with each device.Instructions for prelude (4.Bb.01/2 int from (b)(6) 2003) informs that user must always make sure that: "the resident is sitting firmly and securely fastened, to avoid injuries"."the resident's hands and feet are placed on appropriate rests".Instructions informs also how to assist the resident in entering and removing the resident from a device: "(.) assist the resident to the prelude.When the resident enters the prelude, make sure they place their hands on the hand grips for balance (.) when leaving the cabinet it is easier to back out since the hand grips are used better this way".The received information showed that the patient's left hand slipped off of the rail when being removed from the bath.We find this as unfortunate accident that led to the hand coming between the roller and the rail, and in consequence to the pinched finger.The device was being used for patient care and in that way contributed to the event.Please note also that no malfunction was found that caused or contributed to the reported event and the product's design should not be a case for a cause of this event as the review of complaints on prelude (single event) and the information received in this complaint ("hand slipped off") are showing that if prelude's handling procedures were followed in accordance to product labeling, there would be no patient at risk.

Event Description

It was initially reported to the company representative that "after the bath care giver was taking patient off of the shower chair, patients left hand slipped off of the rail falling in between the roller and the rail pinching the end of his finger".It is unknown what treatment was applied.

• Brand Name: SHOWER CABIN (PRELUDE)
• Type of Device: ILS
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5309557
• MDR Text Key: 33831646
• Report Number: 3007420694-2015-00234
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/18/2015,12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: BBA1254-04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Distributor Facility Aware Date: 12/02/2015
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/18/2015
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2003
• 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): Other