MAUDE Adverse Event Report: COV LP/LLC, AUGUSTA ANALYZER SURGICAL CABLE; PROGRAMMER, PACEMAKER

Model Number 2292

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the cable lock was broken off the plug on the analyzer cable.It was noted that all continuity tests passed and that there was the correct resistance between pins 3 and 5 of 20 kilo ohms.It was additionally noted that there was no intermittent or shorted connections found.Initial mdr 1018120-2020-00005 was submitted to capture the incoming complaint information for this cable.The initial complaint was for 5 cables but this one was returned individually so this mdr was created to capture the return and analysis information.The aware date on this report reflects the analysis completion date as that is the "new information" which warrants another mdr.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the plastic clip at the adapter end of multiple analyzer cables detached during the sterilization process and the cables were then unable to sit securely into the programmer.It was further reported that there had been no change to the sterilization process.The cables are expected to be returned for analysis.There was no patient involvement.It was further reported that the cables were received for analysis.

• Brand Name: ANALYZER SURGICAL CABLE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10397520
• MDR Text Key: 202988632
• Report Number: 1018120-2020-00008
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Date Device Manufactured: 02/18/2019
• 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