MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE INTRA-AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-53

Device Problems Component Falling (1105); Fire (1245); Smoking (1585); Sparking (2595)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

The company representative removed the damaged battery from the customer account and it was shipped to the battery manufacturer's facility.New batteries were provided to the customer.No iabp serial number will be provided since the battery was not installed in any iabp however the battery catalog number is 0146-00-0097 and the battery serial number is (b)(4).The battery pack has been received at the battery manufacturer's facility and is pending the completion of evaluation.The battery pack has been received at the battery manufacturer's facility and is pending the completion of evaluation.

Event Description

Customer reported: flight team was preparing (in their equipment room) additional batteries for patient transport with a cardiosave iabp of unknown serial number.One of the batteries was dropped from an approximate 3 feet height, resulting in sparks followed by smoke and small flame (caused by the plastic casing catching fire).The fire did go out almost immediately and the battery was picked up in a few seconds and removed from the room, however there was enough smoke to set off the smoke alarm in the room.It was also reported several staff members who were in the immediate proximity of the event were directed outside to a well ventilated area.The staff members were not adversely affected by the event, but were reported to have been exposed to at least some amount of smoke from the device.

Manufacturer Narrative

The battery pack was sent to the manufacturer of the battery pack for investigation/evaluation the investigation concluded the battery failure occurred due to the a drop resulting in a damage to one of the internal cells proximal to the connector side of the battery pack.Impact resulted in a physical damage to the cell that in turn resulted in internal short and venting with small fire.All damage was localized to the only cell involved and adjacent wall of the housing.No other cell in the pack was involved in the venting and fire, all other cells maintained their integrity.Updated: date received by mfr, type of reports, if follow-up, what type?, evaluation codes, additional mfr narrative.

Event Description

Customer reported: flight team was preparing (in their equipment room) additional batteries for patient transport with a cardiosave iabp of unknown serial number.One of the batteries was dropped from an approximate 3 feet height, resulting in sparks followed by smoke and small flame (caused by the plastic casing catching fire).The fire did go out almost immediately and the battery was picked up in a few seconds and removed from the room, however there was enough smoke to set off the smoke alarm in the room.It was also reported several staff members who were in the immediate proximity of the event were directed outside to a well ventilated area.The staff members were not adversely affected by the event, but were reported to have been exposed to at least some amount of smoke from the device.

• Brand Name: CARDIOSAVE INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6076730
• MDR Text Key: 59464191
• Report Number: 2249723-2016-00033
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• 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 Number: 1
• Patient Outcome(s): Other