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

Model Number MODEL 100

Device Problems Loose or Intermittent Connection (1371); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Investigation results as follows: device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).A visual inspection of the returned autopulse platform was performed and found that front enclosure was cracked.The autopulse platform is a reusable device and was manufactured on 06/18/2012.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device.A review of the platform archive log showed no problem found in the archive file.The platform was functional tested and the autopulse exhibited no user advisory messages.In summary, the customer's reported complaint of fan is consistently making a loud noise was confirmed.The cause was a paper was stuck in the fan.Therefore the potential root cause was user handling.The paper was removed to remedy the issue.Additionally, during routine service of the platform the lifeband was observed to be loose (unable to lock in place) which is unrelated to the reported complaint.The channel roller assembly was replaced.The platform passed all final testing criteria.

Event Description

It was reported that during shift check, the fan on the autopulse platform was consistently making a loud noise.The customer stated that all other functions on the platform work as expected.There was no patient involvement reported.Unrelated to the complaint, during service of the autopulse platform, it was noted that the lifeband was loose (unable to lock in place).The customer was contacted on 04/27/2016 who informed that they did not experience the lifeband being loose.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5618742
• MDR Text Key: 43992665
• Report Number: 3010617000-2016-00298
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• 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: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• 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