MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE POWER SUPPLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The getinge service territory manager (stm) reported that the portable power supply has a loose power receptacle, one of the long studs/screw that holds on the retaining clip, broke off and fell out. The stm ordered a new portable power supply for replacement and having it shipped directly to customer. No measurement details available, portable power supply is separate from the iabp. The unit was not made available. This was noticed during an inspection of the iabp and accessories.

Event Description

It was reported by the customer that during an inspection of the carrdiosave intra-aortic balloon pump (iabp) and accessories, it was discovered that the portable power supply was damaged. There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE POWER SUPPLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10055744
• MDR Text Key: 193376587
• Report Number: 2249723-2020-00750
• 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,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0014-0085
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse