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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that during a training by the facility's staff, the autopulse platform did not recognize known, good fully charged batteries.The platform indicated that the first battery was empty.The platform performed compressions for two minutes with a second battery but then stopped.With a third battery, the platform started to intermittently power on and off and then stayed off.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Customer indicated that all 3 batteries used were tested in an autopulse charger and passed testing.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 09/15/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the front enclosure was cracked.The physical damage found during visual inspection is not related to the reported event of the autopulse platform not recognizing known good, fully charged batteries.The damage appears to have been caused by normal wear and tear (autopulse manufactured in march of 2011).A review of the autopulse platform's archive was performed and the archive data shows that no sessions occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue was not confirmed.The platform ran with a large resuscitation test fixture (lrtf) for 60 minutes and no faults were observed.In addition, several known, good test batteries were installed into the platform and the device powered up with no problems.No batteries were returned for evaluation.Battery management assessment was performed and no issues were observed.Based on the investigation, the part identified for replacement was the front enclosure.In summary, the reported complaint that the autopulse platform did not recognize known good, fully charged batteries was not confirmed during functional testing.The physical damage found during visual inspection is unrelated to the reported complaint.Upon replacement of the part, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3972126
• MDR Text Key: 4609755
• Report Number: 3003793491-2014-00387
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2011
• 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