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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM SINGAPORE VOLARA, AC,NA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
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HILL-ROM SINGAPORE VOLARA, AC,NA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT Back to Search Results
Model Number M08573
Device Problem Flare or Flash (2942)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Event Description
Hillrom received a report from the customer stating that one of the volara devices caught on fire while being stored in the storage room.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Customer stated that one of their volara devices caught on fire while being stored in the storage room at the account.There was no patient involvement.Upon further follow up with the customer, it was identified that a biomed tech was in the storage room moving devices when the volara device might have moved and caught on fire.The device was not plugged in and not turned on at the time the event occurred.The customer noted it was suspected that the battery on the device started the fire.The volara® system uses oscillation and lung expansion (ole) therapy to help those with cystic fibrosis, neuromuscular disorders, and other chronic conditions clear their airways to maintain health and minimize hospitalizations.Indicated for the mobilization of secretions, lung expansion therapy, and the treatment and prevention of pulmonary atelectasis, the volara® system offers 3-in-1 versatility for chronic patients.No further information is available on the failure at this time.Hillrom is working closely with the customer to secure the device for initial visual inspection of the device and battery ( icc electronics model 194566 ).The investigation is ongoing with the customer to evaluate and assess the device which caught fire.Additionally, hillrom is parallelly working with the supplier of the battery to identify the root cause of the reported event.Additional information, following completion of the investigation will be included in the final report.
 
Event Description
Hillrom received a report from the customer stating that one of the volara devices caught on fire while being stored in the storage room.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Customer stated that one of their volara devices caught on fire while being stored in the storage room at the account.There was no patient involvement.Hillrom informed inventus ( battery pack supplier ) that the 194566 pack in a volara device experienced a thermal event at a hospital.It was reported that a person bumped a cart and the device.The hospital sent the other five batteries that were in their possession.All volaras and batteries were purchased on the same order in (b)(6) 2021.Hospital staff did not collect the 3 battery cells that fell to the floor, so those cells were disposed and not available for analysis.There was no evidence that the battery pack was damaged by external force.The hospital only used the devices with ac power connected, so the returned batteries had only 1 charge cycle in their memory.The 5 returned batteries were manufactured by inventus in late (b)(6) 2019 and received by hillrom in (b)(6) 2019.The batteries shipped out to the hospital in (b)(6) 2021.This means that the battery from the incident likely had only 1 charge in the 28 months between manufacture and the fire incident.The battery remained at full charge from (b)(6) 2021, when the hospital biomedical department deployed the device and battery, to the incident on (b)(6), 2021.It is assumed that the one that caught fire was from that same lot.Based on observations, the fire started in the middle of the battery assembly.Most of the degradation was present at the center of battery pack and the pcba.During the evaluation of the affected battery pack, it was not possible to determine the root cause since most of the sample was destroyed along with the hospitals disposal of key evidence expelled by the cell.5 samples from same lot were evaluated and no workmanship issues were found and there was no corrupted data or abnormalities.Moving forward , supplier inventus committed to several improvements in their design and documentation to reduce risk.The nickel pieces that connect battery cells will have tighter controls for length and polyimide tape will be applied to contact points.Per hillrom feedback, the supplier process failure mode effects analysis (pfmea) will be updated with more consistent wording and terminology between risks.Analysis did not reveal a root cause for the sequence of events that lead to the battery fire.The incident started when a battery cell (manufactured by lg electronics) ejected its contents, exposing lithium to oxygen.Hillrom design, hillrom manufacturing, inventus (battery pack supplier) manufacturing, and hospital abuse were eliminated as potential causes.The issue is believed to be due to a one-off failure of a battery cell.Hillrom will continue to monitor battery complaints , based on this information, no further action is required.
 
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Brand Name
VOLARA, AC,NA
Type of Device
DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
Manufacturer (Section D)
HILL-ROM SINGAPORE
1 yishun avenue 7
singapore, north east 76892 3
SN  768923
Manufacturer Contact
harish vishwanathan
1069 state route 46 east
batesville, IN 47006
3127289851
MDR Report Key12833074
MDR Text Key280927195
Report Number3008145987-2021-00006
Device Sequence Number1
Product Code NHJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192143
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberM08573
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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