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

Model Number MODEL 100

Device Problems Positioning Failure (1158); No Display/Image (1183)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer on 10/9/2015.A li-ion battery (s/n (b)(4)) was also returned with the platform and no issues were observed, as the battery passed the charging test.Visual inspection was performed which found that the load plate was exposed and the battery lock clip was bent.The front enclosure was cracked and the lcd display was also observed to defective, thus confirming the customer's reported complaint.A review of the autopulse platform's archive was performed and no user advisories or warnings were observed on the reported event date.Functional evaluation of the returned autopulse platform was performed and the platform was run for 10 minutes using a large resuscitation test fixture (lrtf), equivalent to a 250 pound patient with no problems.In addition, the reported issue of the lifeband not retracting as intended could not be reproduced.Load cell characterization testing was also performed and both load cells were found to be functioning within specification.Based on the information provided, the parts identified for replacement were the load plate cover, battery lock clip and front enclosure.In summary, the reported complaint of the platform's display being defective was confirmed during visual inspection.The issue of the lifeband not retracting as intended could not be reproduced.Functional testing showed the platform performed as intended.The other physical damages found during visual inspection are unrelated to the customer's reported complaint.The autopulse is a reusable device and therefore, these types of physical damage can occur due to normal wear and tear and/or physical abuse.Following service, including replacement of the damaged parts, the device passed all testing criteria.

Event Description

It was reported that after the autopulse platform was used on a patient, the customer noticed that the platform was able to power on, however the lcd display was blank and the lifeband was unable to retract.No additional details were provided.

• 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: 5167558
• MDR Text Key: 29301464
• Report Number: 3010617000-2015-00573
• 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: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• 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: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1