MAUDE Adverse Event Report: REMINGTON MEDICAL REMINGTON MEDICAL; DISPOSABLE ADAPTER

Lot Number 1907911

Device Problems Loose or Intermittent Connection (1371); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A review of the dhr for this lot of product identified no issues with product quality.All product was 100% inspected for functionality.Based on the information provided by the customer the device did not maintain a secure connection.The defective device from lot 1907911 has been requested for return from the customer to complete the investigation.

Event Description

The director of purchasing reported to remington medical on (b)(6) 2019 a compromised grey clip on the adap-2000.Per the staff using the product, ii was a failure of the clip (pace loc) not holding the (+) and (-) connectors securely which resulted in a loose connection and the patient arrested during installation of temporary pacing cable.Cpr was performed! the patient later had a permanent pacemaker placed and was released from the hospital 48 hours later.

• Brand Name: REMINGTON MEDICAL
• Type of Device: DISPOSABLE ADAPTER
• Manufacturer (Section D): REMINGTON MEDICAL; alpharetta GA
• Manufacturer Contact: matt brown ; 6830 meadowridge court; alpharetta, GA 30005 ; 4707191121
• MDR Report Key: 9319570
• MDR Text Key: 166330757
• Report Number: 1056553-2019-00002
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Lot Number: 1907911
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention