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

Model Number MODEL 100

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, it was found that multiple li-ion batteries were difficult to remove from the platform's battery well.There were no reported error messages.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that user advisory (ua) 45 (not at "home" position after power-on/restart) faults occurred on the reported event date of (b)(6) 2014.Although the customer did not report this, ua 45 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and the encoder cover was found to be damaged.From the condition of the platform, the damage appears to have been due to wear and tear.The platform was functionally tested and the reported issue of difficulty removing batteries from the platform's battery bays was reproduced.Further inspection determined that the cause was due to a damaged pdb battery connector.Unrelated to the reported complaint, user advisory (ua) 45 (not at "home" position after power-on/re-start) faults were observed on the reported event date of (b)(6) 2014.Evaluation of the device did not show any anomalies that could have caused or contributed to the observed ua 45.Based on the archive data, the advisory was likely due to the customer not completely pulling up the lifeband straps prior to the device being turned on.Based on the investigation, the parts identified for replacement were damaged encoder cover as well as the power distribution board in order to remedy the complaint.In summary, the reported complaint of difficulties removing batteries from the platform's battery bays was confirmed during functional inspection and was attributed to a damaged connector on the power distribution board.Unrelated to the reported event, ua 45 faults were observed on the reported event.Based on the full investigation, the likely cause of the ua 45 faults was that the customer did not completely pull up the lifebands prior to turning on the device.Following service, including replacement of the damaged encoder cover and power distribution board, the device passed all test criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4217977
• MDR Text Key: 4976666
• Report Number: 3010617000-2014-00577
• Device Sequence Number: 1
• Product Code: DRM
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2004
• 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