MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB B7

Model Number 07"

Device Problems Device Inoperable (1663); Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 07/05/2014

Event Type  malfunction  

Event Description

It was initially reported by company rep that during process of cleaning the tub, full strength, undiluted chemicals were being added to the tub.It is suspected that they splashed on to the employee's forearm, causing a chemical burn.Plastic gloves were being worn as a ppe (personal protective equipment), however they did not cover the forearms.From received info chemical burn to the caregiver occurred as a result of this incident, due to suspected exposure of undiluted chemical to the forearm.No info about further outcomes were provided.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for height adjustable bath we haven't found any other similar cases.We have been able to establish that there is no complaint trend concerning these kind of events - subjection to disinfectant.The device was inspected by an arjohuntleigh rep at the customer site and found to be out of the spec.The device was being used for pt handling and in that way contributed to the event.Chemical burn occurred as a result of this incident to the caregiver.Complained product is subject to wear and tear.List of recommended steps can be found in product ifu: we have not been able to find any contributing mfg anomalies.Received info showed that the customer was aware of non-functional disinfection unit and had to disinfect device manually.Described event showed that "it is suspected that they [disinfectant] splashed on to the employee's forearm".The splash is not likely to be caused by device itself and these kind of events are considered to be unfortunate accidents.There are also other factors that need to appear to cause this incident e.G: lack of carefulness, incorrect process of disinfection.Therefore, we consider this event to be isolated incident where user wasn't care enough to avoid this incident.Date of last training was not provided, as well as date of last maintenance.Incident description form informs only that last maintenance was made by the customer.We can consider that root cause of this incident is related to user error - not correctly functioning device was used, poor maintenance - disinfection unit was not repaired and normal wear - device was in use for about 21 years.The received info and our eval as described above are showing that if maintenance was followed in accordance ifu, there would be no pt or caregiver at risk.

• Brand Name: B7
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; verkstadsvagen 5, box 61; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4217292
• MDR Text Key: 19089991
• Report Number: 9611530-2014-00053
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07"
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2014
• Distributor Facility Aware Date: 07/08/2014
• Device Age: 21 NA
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2014
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1993
• 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