MAUDE Adverse Event Report: ARJO MED. AB LTD. MK1 POOL LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number DA0542

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Pain (1994); Concussion (2192)

Event Date 09/25/2017

Event Type  Injury  

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 (b)(6) 2010, that number was de-activated due to the site no longer being a manufacturer and until 2014 complaints related to these products were handled by arjo hospital equipment ab and any medwatch reports were submitted under registration #(b)(4) or (b)(4) 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 will be submitted under registration #(b)(4).Additional information will be provided upon investigation conclusion.

Event Description

On (b)(6) 2018 the arjohuntleigh representative was notified about the incident involving mk1 pool lift.The patient was being lifted out of the pool, when cable snapped resulting in patient descending back into the pool in the chair.According to the received information patient sustained an jolt and shock.Day after the incident the patient informed that she was sore all over and was checked by doctor.According the further assessment, patient sustained severe lower back pain, severe pain in both elbows and delayed shock due to incident.After visiting the doctor, the patient also attended the hospital to consult the sustained injuries.As a treatment the patient received strong painkillers.

Manufacturer Narrative

On 2018-jan-30 the arjohuntleigh representative was notified about the incident involving mk1 pool lift which occurred on (b)(6) 2018 in the (b)(6) swimming pool.When the patient (female, (b)(6)) was being lifted out of the shallow end of the pool, the lifting cable (wire rope intended to keep the lift's chair) snapped.As a consequence, the device's chair lowered back into the pool and hit the pool floor.After an issue, the patient was removed from the chair unit and lifted by facility employees to the poolside.According to the received information patient sustained a jolt and shock.Day after the incident the patient informed that she was sore all over and was checked by doctor.According the further assessment, patient sustained severe lower back pain, severe pain in both elbows and delayed shock due to incident.After visiting the doctor, the patient also attended the hospital to consult the sustained injuries.As a treatment the patient received strong painkillers.The involved hoist was quarantined and the service provider was informed about the incident (the lift was not under arjohuntleigh service contract).The review of similar reportable events with the involvement of the mk1 pool lift in last 5 years revealed that number of events related to situation where the lift chair detached from hoist during use due to broke lifting wire rope is very low.Please note that arjohuntleigh was informed about an incident with a significant delay (over 4 months after the event occurrence).Therefore the unit has been already repaired by third party service provider (assured healthcare) when on (b)(6) 2018 the arjohuntleigh representative visited the customer facility to evaluate the device and perform an interview.The device was found in good condition apart from the base of the mast, which was corroded and had a play at column location socket (where the lift column was inserted).The lift was used on the swimming pool in wet and humid environment.During the further evaluation it was detected that the hoist wire rope has been fitted incorrectly and the clutch plate was set wrongly.The customer facility was informed about findings which were flagged to the facility employee, who was in charge on the day of arjohuntleigh representative visit.Following the evaluation results, the hoist was removed from further use.According to the information provided by customer facility representative the previous maintenance was carried out on 2018-jan-17.It was not possible to determine if lifting wire rope has been ever replaced as arjohuntleigh does not have access to the records held by the third party service provider.According to additional information received, the facility confirmed that lift was inspected on 6 monthly basis.The last equipment inspection (comprising loler inspection) of the involved pool lift was performed on (b)(6) 2017.It was stated in the report that lift base was showing signs of corrosion.No other issues were recorded - the lifting wire rope condition was described by third party service provider as good.It was also confirmed that inspection was carried by the contracted party in january 2017, but there was no indication of lifting wire rope condition assessment.Based on the report from this inspection, the previous one was done in july 2016 (record not available).Based on the collected information the users of device located in customer facility did not have access to its operating manual.Operating and product care instructions booklet (ifu/opci, document number (b)(4).Gb issue 3 dated on october 2002), which was delivered to customer with the involved device, provides information and pictographic signs which instruct how to use the pool lift.It provides also the following service related warnings (p.12): "warning: arjo recommend that the pool lift is maintained at regular intervals, see arjo preventative maintenance schedule" "the components listed below are critical to the safe operation of the pool lift and must be regularly examined and replaced at the following intervals: wire rope:- inspect every six months and replace if necessary.Wire rope and drum assembly:- replace regardless of appearance, every two years." according to the information obtained in course of the investigation we were able to establish that unit was inspected by third party service provider twice during the period of one year back from the incident date - in (b)(6) 2017 and (b)(6) 2017.Therefore, the last inspection of the lift incident was performed 2 months before the incident occurrence.The lifting wire rope was not replaced during these inspections and according to the third party work reports it did not reveal wear or defect of this part.As arjohuntleigh does not have access to the service records, which are held by the third party service provider, it was not possible to determine if lifting wire has been ever replaced.Due to late reporting of the incident to arjohuntleigh, the company representative was not able to evaluate the device directly after the event occurrence.However, the evaluation performed on 2018-feb-01 after the arjohuntleigh was notified, revealed that lift was not serviced correctly (last third party maintenance service was performed on 2018-jan-17).The hoist wire rope has been fitted incorrectly and the clutch plate was set wrongly and it had to be removed from use by customer facility until it was repaired by third party service provider.Based on the collected information the involved device was failed to meet the manufacturer's specification as the malfunction occurred.At the time of event the device was used for treatment of the patient (customer of the facility).This issue was reported due to information that involved patient sustained serious injury, which required assessment at the hospital and further pharmacological treatment.

• Brand Name: MK1 POOL LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO MED. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• MDR Report Key: 7233710
• MDR Text Key: 98758206
• Report Number: 3007420694-2018-00026
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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 Caregivers
• Device Model Number: DA0542
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2018
• Distributor Facility Aware Date: 01/30/2018
• Device Age: 14 YR
• Event Location: Other
• Date Report to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 80