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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Scratched Material (3020)
Patient Problem Electric Shock (2554)
Event Date 08/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Arjohuntleigh was made aware an the incident which occurred with the involvement of a non-arjohuntleigh product.
 
Event Description
Arjohuntleigh was made aware of an incident which occurred with the involvement of a non-arjohuntleigh product.It was indicated that the caregiver attempted to move the bed which led to the entrapment of pump power cable within the bed mechanism.Consequently, live and neutral wires of the pump were exposed.The caregiver picked up the cable with his bare hand, when the pump was still plugged to mains supply which resulted in electrical shock.It was indicated that the caregiver visited emergency department, however, did not sustain any further outcomes.Arjohuntleigh have managed to identify the original manufacturer of involved device - the company's name is believed to be ultimate healthcare, device serial number: (b)(4).
 
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Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
MDR Report Key6846806
MDR Text Key86767507
Report Number3005619970-2017-00024
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 09/06/2017
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 No Information
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2017
Distributor Facility Aware Date08/15/2017
Initial Date Manufacturer Received 08/15/2017
Initial Date FDA Received09/06/2017
Type of Device Usage N
Patient Sequence Number1
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