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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH INTRA AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH INTRA AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CARDIOSAVE
Device Problems Burst Container or Vessel (1074); Component Falling (1105); Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4) 2015 11:55 am (gmt-4:00) added by (b)(4): no further information available.When more information become available the device a supplement will be forwarded.
 
Event Description
The customer reported, after completing the transport of a patient to the destination hospital and when stowing away the equipment from the ambulance to the aircraft, in the transition the iabp thomas pack fell from the stretcher (approximately 3-4 ft) landing on the concrete ramp.When the pack struck the ground, the battery exploded, causing a loud noise and a caustic foul odor smoke cloud.The initial cloud and explosion was relatively violent and the bag was kicked away from the aircraft to minimize risk to personnel and aircraft.It was also reported, although the red bag, ecg monitor, iv pump and oxygen cylinder were secured to the aircraft cot, the iabp pack was not.The pack had the normal disposable supplies inside of the bag and one battery, located in the front outside zippered pouch.The outside pouch showed signs of damage due to the event.The additional supplies in the same backpack did not get damaged.
 
Manufacturer Narrative
02/25/2016 08:56 pm (gmt-5:00) added by (b)(4)): the customer provided additional details of the event: after the battery exploded, the battery was hot and continued to smoke for fifteen (15) minutes.Once the battery had been determined by the crew to be extinguished and safe, it was packaged into a plastic looped bag, however after five (5) minutes the bag was hot and the battery had begun to heat up again with minimal smoke.The bag was placed on the concrete outside the fbo once again until it was determined to be safe for transport.The crew took the battery with them to the hotel they were staying at, but made sure the bag was secured and stored outside of the building and away from cars and/or structures.The next morning the battery was cold and showed no additional signs of heat and/or combustion.The battery was secured in the aircraft and transported back to houston, tx (headquarters) for further investigation/evaluation.The customer made the battery available for evaluation however the manufacturer elected not to have the battery returned, due to the corrosiveness and hazardous materials of the battery.The customer provided pictures of the battery damage for further evaluation.The manufacturer reviewed the labeling document, which includes a warning in the ifu: "batteries have the risk of fire, explosion or severe burn hazards.Do not disassemble, crush, heat above 60° c (140° f), or incinerate.Replace only with datascope corp.Ref 0146-00-0097." the same statement is included on the individual battery label.The manufacturer is continuing to investigate this event.
 
Event Description
The customer reported, after completing the transport of a patient to the destination hospital and when stowing away the equipment from the ambulance to the aircraft, in the transition the iabp thomas pack fell from the stretcher (approximately 3-4 ft) landing on the concrete ramp.When the pack struck the ground, the battery exploded, causing a loud noise and a caustic foul odor smoke cloud.The initial cloud and explosion was relatively violent and the bag was kicked away from the aircraft to minimize risk to personnel and aircraft.It was also reported, although the red bag, ecg monitor, iv pump and oxygen cylinder were secured to the aircraft cot, the iabp pack was not.The pack had the normal disposable supplies inside of the bag and one battery, located in the front outside zippered pouch.The outside pouch showed signs of damage due to the event.The additional supplies in the same backpack did not get damaged.
 
Manufacturer Narrative
The battery pack was sent to the manufacturer of the battery pack for investigation/evaluation.The investigation results concluded the event occurred as a result of a fall and the battery pack striking the connector side plate; that caused internally cells have shifted and impacted the proton exchange membranes (pems) on the connector pcba.As a result cells formed two indentations that generated in internal short.The particular cell had vented and melted battery pack casing adjacent to it.
 
Event Description
The customer reported, after completing the transport of a patient to the destination hospital and when stowing away the equipment from the ambulance to the aircraft, in the transition the iabp thomas pack fell from the stretcher (approximately 3-4 ft) landing on the concrete ramp.When the pack struck the ground, the battery exploded, causing a loud noise and a caustic foul odored smoke cloud.The initial cloud and explosion was relatively violent and the bag was kicked away from the aircraft to minimize risk to personnel and aircraft.It was also reported, although the red bag, ecg monitor, iv pump and oxygen cylinder were secured to the aircraft cot, the iabp pack was not.The pack had the normal disposable supplies inside of the bag and one battery, located in the front outside zippered pouch.The outside pouch showed signs of damage due to the event.The additional supplies in the same backpack did not get damaged.
 
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Brand Name
INTRA AORTIC BALLOON PUMP
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key5051635
MDR Text Key25507098
Report Number2249723-2015-01001
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Followup,Followup
Report Date 08/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCARDIOSAVE
Device Catalogue NumberCARDIOSAVE
Other Device ID NumberCA216316I2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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