MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Damaged Prior to Use (2284); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

A production device history record (dhr) review is not required as this complaint is for an out-of-box part failure.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that during testing for field service corrective action the printed circuit board failed "out of the box ".The boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41".There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Corrected field: (the aware date in the initial emdr should read (b)(4) 2018).

Event Description

It was reported that during testing for field service corrective action the printed circuit board failed "out of the box." the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41".There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

It was reported by a company representative that the necessary repairs were made and the iabp was functioning properly.Subsequently, the failed out of box part was returned to our national repair center for evaluation.A senior repair technician inspected the part and no visual damage was observed.The datasettes were installed into a main board of the cs100 test fixture and was tested to factory specifications per cs100 service manual.The datasettes failed testing and the reported failure was verified.The datasettes were then sent to the supplier for failure analysis per procedure and the supplier was able to verify the reported failure.They stated that u1 was not programmable and not cost effective to repair.The datasette was scrapped and retained in the nrc per procedure.

Event Description

It was reported that during testing for field service corrective action the printed circuit board failed "out of the box." the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41".There was no patient involvement and no adverse event was reported.

Event Description

It was reported that during testing for field service corrective action the printed circuit board failed "out of the box." the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41".There was no patient involvement and no adverse event was reported.This complaint has been identified as a duplicate to another.Please note that all relevant information regarding this event has been captured and submitted under mfg report # 2249723-2018-00935.

Manufacturer Narrative

This complaint has been identified as a duplicate to another.Please note that all relevant information regarding this event has been captured and submitted under mfg report # 2249723-2018-00935.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7903439
• MDR Text Key: 121718930
• Report Number: 2249723-2018-01648
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1