MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform (sn (b)(4)) was confirmed in the archive review but not during the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported event.Upon visual inspection, observed cracked front enclosure on the platform, unrelated to the reported complaint.The enclosure needs to be replaced to remedy this issue.The platform passed initial functional testing and run-in test using the 95% patient test fixture (lrtf) without any fault or error.Review of the archive data shows (ua) 41 (patient surface temperature sensor malfunction) error message occurred on the reported event date ((b)(6) 2018).Additionally, as a precautionary measure, the temperature sensor cable was replaced to avoid future ua 41 reoccurrence.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

As reported, the autopulse platform (sn (b)(4)) displayed user advisory 41 (patient surface temperature sensor malfunction) error message.No known impact or consequence to the patient.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8131513
• MDR Text Key: 129474710
• Report Number: 3010617000-2018-01224
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2015
• 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