MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU; BATH, HYDRO-MASSAGE

Model Number AJR7112-GB

Device Problems Misassembled (1398); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon investigation conclusion.

Event Description

On 2018-jan-24 arjohuntleigh was notified by customer facility about event with involvement of malibu bathtub (serial number: (b)(4)), which occurred on (b)(6) 2018.The customer facility employees found that the bath chair was sitting at an angle and discovered that the chair safety clip appeared to be reversed.At this time no patient was on the chair, but it was not confirmed if the bath was used for therapy.When on 2018-jan-25 the arjohuntleig representative attended customer facility, no issues were found.The customer facility representative confirmed that they had refitted the safety clips on both baths.

Manufacturer Narrative

Information regarding visit at the customer facility which took place on (b)(6) 2018 were found to be inaccurate and required clarification.This is a follow-up to the report to present revised information collected and investigation conclusion: on 2018-jan-24 , arjohuntleigh was notified by customer facility about an event with involvement of malibu bathtub (serial number: (b)(4), which occurred on (b)(6) 2018.The customer facility employees found that the bath chair was at an angle.It was discovered that the chair locking fitting element appeared to be mounted conversely.There was no adverse event and at this time no patient was on the chair.On (b)(6) 2018, the arjohuntleigh representative attended the customer facility and during the device inspection confirmed that locking fitting was not attached correctly and repositioned this element.The further evaluation of the bathtub revealed good technical device condition and lack of any other deviation.The review of reportable events with the involvement of the malibu in last 5 years revealed that this was a first time arjohuntleigh was notified about this kind of complaint.Therefore we deem this was a single occurrence issue.The malibu/sovereign bathtub is equipped with detachable chair and lift arm for transfer of the patient.The lift arm is attached to the actuator by three countersunk bolts.The bath chair is equipped with two hooks on which the chair hangs when is mounted on the lifting arm.Moreover, the lifting arm has a guide pin which while the chair is being attached to the lift arm is inserted into the chair and provides additional support.According to the bathtub evaluation results, the device was in good condition and all these described elements of lifting arm were present on the device.It was confirmed that the construction of bathtub lifting arm provided proper stability of the chair.Based on this information the likelihood of occurrence of serious deterioration in state of health was found negligible and it do not suggest this issue caused by itself any immediate risk for a patient.This complaint was initially reported to the competent authority in abundance of caution, based on initial allegation suggesting instability of the device chair.Please note that malibu operating and product care instructions [opci 04.Au.02-3gb dated on march 2003] which was delivered to customer with the claimed device provides information and warnings related to safe usage of the bathtub including locking and securing the lift chair."warning! before using the transfer chair, make sure it is safely attached to the lift arm and that the locking mechanism is thoroughly locked." (p.4) "warning! before using the transfer chair always make sure that it is safely attached to the lift arm." (p.15).The opci provides also instructions regarding correct connecting and disconnecting the transfer chair including figures showing how to attach the locking fitting properly."make sure the hooks are securely attached to the lift arm and that safety catch is in place." please note that this bathtub was under the arjohuntleigh maintenance contract and last service was performed on 2017-dec-07, when the arjohuntleigh representative performed maintenance service without any part replacement.The device was also serviced on 2017-may-04 (replacement of steering box - not related to the issue), 2017-oct-09 (annual maintenance) and on (b)(6) 2017, when customer facility was visited again by arjohuntleigh representative to perform replacement of lift arm and middle pipe.It was also confirmed that safety catch/clip was never replaced.Following the reports of services performed by the arjohuntleigh representative no abnormality related to the safety catch was detected.Based on the collected information the involved device failed to meet the manufacturer's specification as the locking fitting was not mounted properly.At the time of event the device was not used with a patient.Please note that no adverse event occurred in this case.This complaint was reported to competent authorities based on initial information, however upon receiving additional information and clarification of the event circumstances, it was concluded that this incident does not meet the definition of mdr adverse event and will not be considered as such in the future.

Event Description

On 2018-jan-24 arjohuntleigh was notified by customer facility about event with involvement of malibu bathtub (serial number: (b)(4)), which occurred on 2018-jan-12.The customer facility employees found that the bath chair was sitting at an angle and discovered that the chair safety clip appeared to be reversed.At this time no patient was on the chair, but it was not confirmed if the bath was used for therapy.When on 2018-jan-25 the arjohuntleig representative attended customer facility, no issues were found.The customer facility representative confirmed that they had refitted the safety clips on both baths.

Manufacturer Narrative

On 2018-jan-24 arjohuntleigh was notified by customer facility about the event with the involvement of malibu bathtub (serial number: (b)(4)), which occurred on 2018-jan-12.The customer facility employees found that the bath chair was at an angle and discovered that the chair safety clip was installed conversely.At this time no patient was on the chair, but it was not confirmed if the bath was used for therapy before failure was found.When on 2018-jan-25 the arjohuntleigh representative attended customer facility, no technical deficiency was found.The customer facility representative confirmed that they had refitted the safety clip on the bath.The further evaluation of the device revealed that it was in good condition and no other malfunction was detected.The review of similar reportable events with the involvement of the malibu in last 5 years revealed low number of events related to the situation where safety clip was not properly locked.Please note that this bathtub was under the arjohuntleigh maintenance contract and the last service was performed on 2017-dec-07, when the arjohuntleigh representative performed maintenance service without any part replacement.The device was also serviced on 2017-may-04 (replacement of steering box - not related to the issue), 2017-oct-09 (annual maintenance) and on 2017-oct-20, when customer facility was visited again by arjohuntleigh representative to perform replacement of lift arm, middle pipe and battery.It was also confirmed by arjohuntleigh service department that safety catch/clip had been never replaced.Following the reports of services performed by the arjohuntleigh representative no abnormality related to the safety catch was detected.This was the first time customer facility notified the arjohuntleigh representative about this kind of malfunction.Please note that malibu operating and product care instructions [04.Au.02-3gb dated on march 2003] which was delivered to the customer with the claimed device provides information and warnings related to safe usage of the bathtub including locking and securing the lift chair: "warning! before using the transfer chair, make sure it is safely attached to the lift arm and that the locking mechanism is thoroughly locked." (p.4) "warning! before using the transfer chair always make sure that it is safely attached to the lift arm." (p.15) the opci provides also instructions regarding correct connecting and disconnecting the transfer chair including pictures showing the safety catch locking as well (p.11-12).The instructions show the proper positioning of chair or application of safety catch and should be confronted with the condition of the device to prevent the event from occurrence."make sure the hooks are securely attached to the lift arm and that safety catch is in place." according to the preventive maintenance schedule provided within opci the qualified personnel during service of the device should: "check/replaced safety catches on lift arm and chassis." (p.21) the involved device was under the arjohuntleigh service contract and its last preventive maintenance was performed in 2017-dec-07.According to this information no malfunction of the safety catch was noted during this service and was not recorded in the report.It should be underlined that opci informs the user that device alterations may cause a potential hazard to the resident: "unauthorized modifications on any arjohuntleigh equipment may affect its safety." (p.3) based on the collected information the involved device failed to meet the manufacturer's specification as the safety clip was wrongly fitted.At the time of the event the device was used for treatment of the patient (customer of the facility).Please note that no adverse event occurred in this case.This complaint was decided to be reported to the competent authorities in abundance of caution, due to the potential of serious injury if the event would reoccur and if the malfunction was not detected.Also, because of the limited information available justifying why safety catch was retrofitted by customer facility before the bathtub was made available for arjohuntleigh representative evaluation.Please note that section b.5 was corrected as wrong data was submitted in the initial report, fields f.3-5 were corrected due to change of contact person and fields g.1-2 were modified because of e-mail address change.

• Brand Name: MALIBU
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7293012
• MDR Text Key: 101146054
• Report Number: 3007420694-2018-00047
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AJR7112-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Distributor Facility Aware Date: 01/24/2018
• Device Age: 14 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: 02/24/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/24/2018; 02/24/2018
• Supplement Dates FDA Received: 03/20/2018; 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other