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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB BOLERO; LIFT, PATIENT, NON-AC-POWERED
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ARJO HOSPITAL EQUIPMENT AB BOLERO; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number CEB6001-01
Device Problems Microbial Contamination of Device (2303); Contamination /Decontamination Problem (2895); Material Split, Cut or Torn (4008)
Patient Problems Bacterial Infection (1735); Post Traumatic Wound Infection (2447)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
Please note that previous medwatch reports for this product may have been submitted under the registration number 9611530.Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.The involved device was evaluated by the arjo representative.According to the results of inspection, the device¿s mattress was worn and damaged at the place where it is attached to the stretcher.The investigation is on-going and further information will be provided in the next report.
 
Event Description
Arjo was notified about an incident with involvement of bolero bathing lift.It was reported by the customer facility that the patient of the burn wound centre was infected with a pseudomonas bacterium.Patient had an open wound which made it possible to get infected.No information regarding treatment was provided.The customer facility performed an internal investigation to find a possible cause of the infection and determined that the patient was using the bolero lift for bathing.The device¿s mattress was worn and damaged at the place where it is attached to the stretcher.According to the customer facility¿s representative, water was able to enter the mattress, which according to the allegation may have contributed to the patient¿s infection.No microbiological test results have been provided to date.The mattress was taken out of use.
 
Manufacturer Narrative
The customer facility conducted microbiological tests, which confirmed presence of bacteria in water from the mattress.The mattress was immediately taken out of use by the customer facility.The investigation is on-going an further information will be provided in the next report.
 
Manufacturer Narrative
The information collection and analysis for purpose of investigation is on-going.Additional information will be provided in the next report.
 
Manufacturer Narrative
Arjo was notified about an incident with involvement of bolero bathing lift.It was reported by the customer facility that the patient of the burn wound centre was infected with a pseudomonas aeruginosa bacterium.Patient had an open wound which made it possible to get infected.No information regarding treatment was provided.The customer facility performed an internal investigation to find a possible cause of the infection and determined that the patient was using the bolero lift for bathing.The device¿s mattress was worn and damaged at the place where it is attached to the stretcher.The mattress was immediately taken out of use by the customer facility.According to the customer facility¿s representative, water was able to enter the mattress, which as per the allegation may have contributed to the patient¿s infection.The customer facility conducted microbiological tests, which confirmed presence of bacteria in water from the mattress.The mattress was disposed of by the customer facility and arjo was not able to evaluate it.The photographic evidence was also not available.The bolero instructions for use (ifu; 04.Ce.01/8gb dated on september 2009) provides information substantial for correct and safe usage of the device.Ifu includes the procedure for attachment and detachment of the mattress together with supporting illustrations.According to ifu, the claimed lift and its mattress should be cleaned and disinfected after every use and at the end of the day following the provided procedure.Bolero is subject to wear and tear, and the maintenance actions must be performed when specified to ensure that the product remains within its original manufacturing specification.The ifu provides user with care and preventive maintenance schedule which advises what parts of the device and how often should be checked.Bolero has to be serviced annually by qualified personnel according to the preventive maintenance schedule.The schedule include actions that are recommended to be performed by caregiver, also for the device¿s mattress.User should check mattress at least every week to make sure there are no cracks or tears that would allow water to get into the filling of the mattress.If there is such damage, it is recommended to replace the damaged parts.The provided obligations are minimum the manufacturer recommends.In some cases due to heavy use of the product and exposure to aggressive environment, more frequent inspections should be carried out.Arjo informs via ifu that continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety.Based on the collected information it was not possible to establish the exact root cause as the mattress was not available for evaluation, but according to the ifu this accessory should be regularly checked for damages and removed from service if any issue is detected.According to the customer facility allegation, the mattress¿ malfunction contributed to the patient infection.Please note that there was another similar incident, which was reported by the same customer facility, but claimed infection of a different patient (fda mfr report number: 3007420694-2020-00176).In summary, the inspection of the device was not performed by arjo and no conclusion could have been drawn.According to the information received from the customer facility reporting this incident, the device did not perform as intended due to damage.It was reported that the device contributed to the patient infection and microbiological test confirmed presence of bacteria in the water from the mattress, so in this way the device played a role in the event.Please note the pseudomonas aeruginosa infections are common in burn patients and the exposure to the bacteria can come from many different sources.This complaint was decided to be reported to the regulatory authorities due to allegation of patient's wound infection related to use of the bolero bathing lift with a damaged accessory.H3 other text : defective mattress was disposed of.
 
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Brand Name
BOLERO
Type of Device
LIFT, PATIENT, NON-AC-POWERED
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW  24121
MDR Report Key10884834
MDR Text Key217685666
Report Number3007420694-2020-00177
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCEB6001-01
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age13 YR
Patient Weight54
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